Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies

June 1, 2021 updated by: Pfizer

A PROTOCOL TO MONITOR FROM BIRTH TO AGE 15 MONTHS THE NEUROLOGICAL DEVELOPMENT OF INFANTS WITH EXPOSURE IN-UTERO IN TANEZUMAB CLINICAL STUDIES AT ALL INVESTIGATIONAL SITES

A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Keck School of Medicine
    • Florida
      • Sarasota, Florida, United States, 34232
        • Gulfcoast Research Institute
      • Sarasota, Florida, United States, 34232
        • Kennedy and White Orthopaedic Center
      • Tampa, Florida, United States, 33609
        • Pediatric Epilepsy & Neurology Specialists
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • Lafayette Clinical Research Group
      • Lafayette, Indiana, United States, 47905
        • Preferred Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study.
  • The infant's mother (who was the tanezumab clinical study participant) must review, agree and sign an informed consent document explaining the details of the perinatal and post natal follow up. Where local regulations mandate, the male parent would also review and sign the informed consent.
  • Parents or legal guardian must be willing and able to comply with scheduled visits and study procedures.

Exclusion Criteria:

  • There are no exclusion criteria for participating in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Cohort 1
Long term observational study of subjects from tanezumab parent study
Drug: Investigational medical product (IMP) administered in parent study
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Any visit during participants' age from 0 to 2 Months
Occipital-frontal Head Circumference at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
At 8 Months of participants' age
Occipital-frontal Head Circumference at 15 Months of Participant's Age
Time Frame: At 15 Months of participants' age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
At 15 Months of participants' age
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Any visit during participants' age from 0 to 3 Months
Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Occipital-frontal head circumference of participants in cm was reported.
Any visit during participants' age above 3 Months and up to 6 Months
Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Occipital-frontal head circumference of participants in cm was reported.
Any visit during participants' age above 6 Months and up to 9 Months
Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Occipital-frontal head circumference of participants in cm was reported.
Any visit during participants' age above 15 Months and up to 18 Months
Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Occipital-frontal head circumference of participants in cm was reported.
Any visit during participants' age above 21 Months and up to 24 Months
Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Occipital-frontal head circumference of participants in cm was reported.
Any visit during participants' age above 24 Months and up to 30 Months
Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Body length of participants in cm was reported.
Any visit during participants' age from 0 to 2 Months
Body Length at 8 Months of Participant's Age
Time Frame: At 8 Months of participant's age
Body length of participants in cm was reported.
At 8 Months of participant's age
Body Length at 15 Months of Participant's Age
Time Frame: At 15 Months of participant's age
Body length of participants in cm was reported.
At 15 Months of participant's age
Body Length During 0 to <=3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Body length of participants in cm was reported.
Any visit during participants' age from 0 to 3 Months
Body Length During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Body length of participants in cm was reported.
Any visit during participants' age above 3 Months and up to 6 Months
Body Length During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Body length of participants in cm was reported.
Any visit during participants' age above 6 Months and up to 9 Months
Body Length During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Body length of participants in cm was reported.
Any visit during participants' age above 15 Months and up to 18 Months
Body Length During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Body length of participants in cm was reported.
Any visit during participants' age above 21 Months and up to 24 Months
Body Length During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Body length of participants in cm was reported.
Any visit during participants' age above 24 Months and up to 30 Months
Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Body weight of participants in kilogram (kg) was reported.
Any visit during participants' age from 0 to 2 Months
Body Weight at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Body weight of participants in kilogram (kg) was reported.
At 8 Months of participants' age
Body Weight at 15 Months of Participant's Age
Time Frame: At 15 Months of participants' age
Body weight of participants in kilogram (kg) was reported.
At 15 Months of participants' age
Body Weight During 0 to <=3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Body weight of participants in kilogram (kg) was reported.
Any visit during participants' age from 0 to 3 Months
Body Weight During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Body weight of participants in kg was reported.
Any visit during participants' age above 3 Months and up to 6 Months
Body Weight During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Body weight of participants in kg was reported.
Any visit during participants' age above 6 Months and up to 9 Months
Body Weight During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Body weight of participants in kg was reported.
Any visit during participants' age above 15 Months and up to 18 Months
Body Weight During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Body weight of participants in kg was reported.
Any visit during participants' age above 21 Months and up to 24 Months
Body Weight During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months up to 30 Months
Body weight of participants in kg was reported.
Any visit during participants' age above 24 Months up to 30 Months
Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Any visit during participants' age from 0 to 2 Months
Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
At 8 Months of participants' age
Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age
Time Frame: At 15 Months participants' age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
At 15 Months participants' age
Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Any visit during participants' age from 0 to 3 Months
Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Systolic and diastolic blood pressure of participants in mmHg was reported.
Any visit during participants' age above 3 Months and up to 6 Months
Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Systolic and diastolic blood pressure of participants in mmHg was reported.
Any visit during participants' age above 6 Months and up to 9 Months
Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Systolic and diastolic blood pressure of participants in mmHg was reported.
Any visit during participants' age above 15 Months and up to 18 Months
Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Systolic and diastolic blood pressure of participants in mmHg was reported.
Any visit during participants' age above 21 Months and up to 24 Months
Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Systolic and diastolic blood pressure of participants in mmHg was reported.
Any visit during participants' age above 24 Months and up to 30 Months
Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Pulse rate of participants in beats per minute was reported.
Any visit during participants' age from 0 to 2 Months
Pulse Rate at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Pulse rate of participants in beats per minute was reported.
At 8 Months of participants' age
Pulse Rate at 15 Months of Participant's Age
Time Frame: At 15 Months of participants' age
Pulse rate of participants in beats per minute was reported.
At 15 Months of participants' age
Pulse Rate During 0 to <=3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Pulse rate of participants in beats per minute was reported.
Any visit during participants' age from 0 to 3 Months
Pulse Rate During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Pulse rate of participants in beats per minute was reported.
Any visit during participants' age above 3 Months and up to 6 Months
Pulse Rate During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Pulse rate of participants in beats per minute was reported.
Any visit during participants' age above 6 Months and up to 9 Months
Pulse Rate During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Pulse rate of participants in beats per minute was reported.
Any visit during participants' age above 15 Months and up to 18 Months
Pulse Rate During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Pulse rate of participants in beats per minute was reported.
Any visit during participants' age above 21 Months and up to 24 Months
Pulse Rate During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Pulse rate of participants in beats per minute was reported.
Any visit during participants' age above 24 Months and up to 30 Months
Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Temperature of participants in degree Celsius was reported.
Any visit during participants' age from 0 to 2 Months
Temperature at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Temperature of participants in degree Celsius was reported.
At 8 Months of participants' age
Temperature at 15 Months of Participant's Age
Time Frame: At 15 Months of participants' age
Temperature of participants in degree Celsius was reported.
At 15 Months of participants' age
Temperature During 0 to <=3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Temperature of participants in degree Celsius was reported.
Any visit during participants' age from 0 to 3 Months
Temperature During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Temperature of participants in degree Celsius was reported.
Any visit during participants' age above 3 Months and up to 6 Months
Temperature During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Temperature of participants in degree Celsius was reported.
Any visit during participants' age above 6 Months and up to 9 Months
Temperature During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Temperature of participants in degree Celsius was reported.
Any visit during participants' age above 15 Months and up to 18 Months
Temperature During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Temperature of participants in degree Celsius was reported.
Any visit during participants' age above 21 Months and up to 24 Months
Temperature During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Temperature of participants in degree Celsius was reported.
Any visit during participants' age above 24 Months and up to 30 Months
Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Respiratory rate of participants in breaths per minute was reported.
Any visit during participants' age from 0 to 2 Months
Respiratory Rate at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Respiratory rate of participants in breaths per minute was reported.
At 8 Months of participants' age
Respiratory Rate at 15 Months of Participant's Age
Time Frame: At 15 Months participants' age
Respiratory rate of participants in breaths per minute was reported.
At 15 Months participants' age
Respiratory Rate During 0 to <=3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Respiratory rate of participants in breaths per minute was reported.
Any visit during participants' age from 0 to 3 Months
Respiratory Rate During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Respiratory rate of participants in breaths per minute was reported.
Any visit during participants' age above 3 Months and up to 6 Months
Respiratory Rate During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Respiratory rate of participants in breaths per minute was reported.
Any visit during participants' age above 6 Months and up to 9 Months
Respiratory Rate During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Respiratory rate of participants in breaths per minute was reported.
Any visit during participants' age above 15 Months and up to 18 Months
Respiratory Rate During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Respiratory rate of participants in breaths per minute was reported.
Any visit during participants' age above 21 Months and up to 24 Months
Respiratory Rate During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Respiratory rate of participants in breaths per minute was reported.
Any visit during participants' age above 24 Months and up to 30 Months
Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Any visit during participants' age from 0 to 2 Months
Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
At 8 Months of participants' age
Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age
Time Frame: At 15 Months of participants' age
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
At 15 Months of participants' age
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)
Time Frame: Follow-up Visit 1 (At the age of Month 20)
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Follow-up Visit 1 (At the age of Month 20)
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)
Time Frame: Follow-up Visit 2 (At the age of 26 Months)
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Follow-up Visit 2 (At the age of 26 Months)
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age
Time Frame: At 8 Months of participants' age
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
At 8 Months of participants' age
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age
Time Frame: At 15 Months of participants' age
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
At 15 Months of participants' age
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)
Time Frame: Follow-up Visit 1 (At the age of Month 20)
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Follow-up Visit 1 (At the age of Month 20)
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)
Time Frame: Follow-up Visit 2 (At the age of Month 26)
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.
Follow-up Visit 2 (At the age of Month 26)
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age
Time Frame: At 8 Months of participants' age
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
At 8 Months of participants' age
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age
Time Frame: At 15 Months of participants' age
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
At 15 Months of participants' age
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 1 (Month 20 of Participant's Age)
Time Frame: Follow-up Visit 1 (At the age of Month 20)
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Follow-up Visit 1 (At the age of Month 20)
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 2 (Month 26 of Participant's Age)
Time Frame: Follow-up Visit 2 (At the age of Month 26)
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Follow-up Visit 2 (At the age of Month 26)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 4, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A4091065
  • 2013-002548-10 (EudraCT Number)
  • INFANT SAFETY FOLLOW-UP #2 (Other Identifier: Alias Study Number)
  • NEONATAL MONITORING STUDY #2 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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