Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

March 2, 2021 updated by: Abbott Nutrition

Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.

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.

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.
Observational

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.
320

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

  • Turkey
      • Adana, Turkey, 01150
        • Adana City Hospital
      • Afyon, Turkey, 03200
        • Afyon Kocatepe University Medical Faculty
      • Ankara, Turkey, 06590
        • Ankara University Medical Faculty
      • Ankara, Turkey, 06080
        • Ankara Dr. Sami Ulus Women and Child Disesase Research and Training Hospital B
      • Ankara, Turkey, 06100
        • Hacettepe Üniversitesi University Medical Faculty A
      • Ankara, Turkey, 06100
        • Hacettepe Üniversitesi University Medical Faculty B
      • Ankara, Turkey, 06110
        • Ankara Dışkapı Child Disease Hospital A
      • Ankara, Turkey, 06110
        • Ankara Dışkapı Child Disease Hospital B
      • Ankara, Turkey, 06230
        • Ankara Research and Training Hospital
      • Ankara, Turkey, 06370
        • Ankara Yıldırım Beyazıt University Yenimahalle Research and Training Hospital
      • Ankara, Turkey, 06500
        • Gazi Üniversitesi University Medical Faculty
      • Antalya, Turkey, 07070
        • Akdeniz University Medical Faculty A
      • Antalya, Turkey, 07070
        • Akdeniz University Medical Faculty B
      • Balıkesir, Turkey, 10145
        • Balıkesir University Research and Training Hospital
      • Bursa, Turkey, 16310
        • TC Sağlık Bilimleri University Bursa Yuksek Intisas Research and Training Hospital
      • Denizli, Turkey, 20070
        • Pamukkale University Medical Faculty A
      • Denizli, Turkey, 20070
        • Pamukkale University Medical Faculty B
      • Elazığ, Turkey, 23119
        • Fırat Üniversitesi University Medical Faculty
      • Erzurum, Turkey, 25070
        • Erzurum Research and Training Hospital
      • Gaziantep, Turkey, 27310
        • Gaziantep University Medical Faculty
      • Hatay, Turkey, 31001
        • Hatay State Hospital
      • Istanbul, Turkey, 34230
        • Istanbul Esenler Women and Children Diseases Hospital
      • Kocaeli, Turkey, 41380
        • Kocaeli Üniversitesi University Medical Faculty
      • Konya, Turkey, 42060
        • Konya Necmettin Erbakan University Medical Faculty
      • Konya, Turkey, 42080
        • Konya Başkent University Hospital
      • Konya, Turkey, 42130
        • Konya Selcuk University Medical Faculty
      • Kırıkkale, Turkey, 71450
        • Kırıkkale University Medical Faculty
      • Malatya, Turkey, 44280
        • İnönü Üniversitesi University Medical Faculty
      • Samsun, Turkey, 55040
        • Samsun Research and Training Hospital
      • Trabzon, Turkey, 61080
        • Karadeniz Teknik University Medical Faculty
      • Trabzon, Turkey, 61290
        • Trabzon Kanuni Research and Training Hospital
      • Zonguldak, Turkey, 67000
        • Zonguldak Bülent Ecevit University Research and Training Hospital
      • İstanbul, Turkey, 34093
        • İstanbul University İstanbul Medical School A
      • İstanbul, Turkey, 34098
        • Istanbul University Cerrahpasa Medical School
      • İstanbul, Turkey, 34147
        • İstanbul Bakırköy Dr. Sadi Konuk Research and Training Hospital
      • İstanbul, Turkey, 34303
        • İstanbul Atakent Acıbadem Hospital
      • İstanbul, Turkey, 34303
        • İstanbul Kanuni Sultan Süleyman Research and Training Hospital A
      • İstanbul, Turkey, 34371
        • İstanbul Sisli Hamidiye Etfal Research and Training Hospital C
      • İstanbul, Turkey, 34371
        • İstanbul Şişli Hamidiye Etfal Research and Training Hospital A
      • İstanbul, Turkey, 34371
        • İstanbul Şişli Hamidiye Etfal Research and Training Hospital B
      • İstanbul, Turkey, 34384
        • İstanbul Okmeydanı Research and Training Hospital
      • İstanbul, Turkey, 34457
        • İstanbul Maslak Acıbadem Hospital
      • İstanbul, Turkey, 34662
        • İstanbul Altunizade Acıbadem Hospital
      • İstanbul, Turkey, 34722
        • İstanbul Göztepe Research and Training Hospital
      • İstanbul, Turkey, 34764
        • İstanbul Ümraniye Research and Training Hospital A
      • İstanbul, Turkey, 34764
        • İstanbul Ümraniye Research and Training Hospital B

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 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be enrolled from outpatient clinics and physician offices.

Description

Inclusion Criteria:

  • Infant is experiencing persistent feeding intolerance or allergy and diagnosed wtih Cow's Milk Protein Allergy (CMPA) or other condition where an extensively hydrolyzed formula is deemed appropriate by their healthcare professional
  • Infants using OTC medications, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance
  • Parent(s) of infants enrolled on prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids directed by their healthcare professional, confirm their intention to continue their use during the study until directed by their healthcare professional to discontinue.
  • Infant is not receiving steroids.
  • Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
  • Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study
  • Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrollment through the duration of the study
  • Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB)

Exclusion Criteria:

  • Participation in another study that has not been approved as a concomitant study by AN

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

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
Weight
Time Frame: Baseline to Study Day 30
Measured in Kg
Baseline to Study Day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Formula Intake
Time Frame: Baseline to Study Day 30
Parent completed diary
Baseline to Study Day 30

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.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Aysugul Alptekin, MD, Abbott Turkey

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.
January 31, 2018

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.
March 27, 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.
March 27, 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).
July 13, 2018

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.
July 13, 2018

First Posted (Actual)

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.
July 24, 2018

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.
March 3, 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.
March 2, 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.
March 1, 2021

More Information

Terms related to this study

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.
  • DA16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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