Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial (MoCHA)

July 30, 2024 updated by: NICHD Neonatal Research Network

Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity

The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

Study Overview

Status

Status

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

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

Study subjects will be patients in the NICU at one of the participating hospitals at a Neonatal Research Network site. Infants who meet the eligibility criteria will be randomized to either caffeine citrate at 10 mg/kg/dose or placebo (equal volume of all the excipients except for the active ingredient, caffeine citrate) to be given daily beginning within 72 hours of open label caffeine discontinuation. The infant may still require hospitalization for observation after discontinuation of open label caffeine or for other discharge issues such as temperature control or feeding tolerance.

Once deemed ready for discharge, infants will be continued at home on the same dose of caffeine citrate or placebo for the first 28 days after hospital discharge. On the day of discharge, the parent will be supplied with 28 numbered vials with oral caffeine citrate (intervention group) or placebo at an equivalent volume (placebo group).

The parents will be educated by the research nurse, discharge nurse, physician, or pharmacist on storage and administration of study medication. A member of the research team will contact the parents to obtain post-discharge information within 72 hours after discharge, once a week for the first 4 weeks, and biweekly during the weeks 5 to 8 after discharge.

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.
827

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Abhik Das, PhD
  • Phone Number: 301-230-4640

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Durham, North Carolina, United States, 27705
        • RTI International
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Cincinnati Children's Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University, Rainbow Babies and Children's Hospital
      • Columbus, Ohio, United States, 43205
        • Research Institute at Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Brown University, Women & Infants Hospital of Rhode Island
    • Texas
      • Dallas, Texas, United States, 75235
        • University Of Texas Southwestern Medical Center At Dallas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah

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

6 months to 7 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inborn and outborn infants of 29 0/7 to 33 6/7 weeks gestational age at birth
  • admitted to hospitals of the NICHD NRN who, are at time of enrollment:
  • ≤35 6/7 weeks post-menstrual age at the time of randomization
  • Receiving caffeine with plan to discontinue treatment or just discontinued caffeine treatment
  • Receiving feeds at a volume of ≥120 ml/kg/day by oral and/or tube feeding
  • Ability to start study medication within 72 hours after stopping caffeine

Exclusion Criteria:

  • On respiratory therapy (oxygen more than room air equivalent for high altitude sites, nasal cannula, continuous positive pressure ventilation, and/or mechanical ventilation)
  • Infants who would otherwise be discharged home on apnea monitor due to underlying disease or family history, including history of a sibling with sudden infant death syndrome
  • Parental request for apnea monitor
  • Congenital heart disease other than atrial septal defect, ventricular septal defect, or patent ductus arteriosus
  • Neuromuscular conditions affecting respiration
  • Major congenital malformation and/or genetic disorder
  • Plans to transfer to a non-NRN site before discharge
  • Unable to obtain parental or guardian consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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.
Experimental: Caffeine Citrate
Caffeine citrate at 10 mg/kg/dose (5 mg/kg caffeine base) daily, in hospital. Infants will continue at home on the same dose of caffeine citrate for the first 28 days after hospital discharge.
Drug: Caffeine Citrate
The study intervention is caffeine citrate given once daily at 10 mg/kg/day. It is given orally, before hospital discharge and 28 days after discharge.
Placebo Comparator: Placebo
Placebo contains all of the excipients except for the active ingredient, caffeine citrate, (a volume equivalent to 10 mg/kg of caffeine citrate) and given daily. Infants will be continued at home on the same dose of placebo for the first 28 days after hospital discharge.
Drug: Placebo
The study intervention is placebo given once daily at a volume equivalent to 10 mg/kg of caffeine citrate. It is given orally, before hospital discharge and 28 days after discharge.

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
Number of Days Between Randomization and Hospital Discharge
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of days between randomization and hospital discharge. This outcome is censored at 48 weeks PMA and at time of transfer or death.
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge
Time Frame: Discharge through 4 weeks post-discharge
Number of sick visits related to apneic or apparent life-threatening events within first 4 weeks post-discharge MEASTYPE=SEC
Discharge through 4 weeks post-discharge

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
The Number of Days to Physiologic Maturity After Randomization
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of days to physiologic maturity after randomization. Physiologic maturity is defined: 1. Temperature: out of the incubator for at least 48 hours with normal body temperature; 2. Feeding: oral feeding at a volume of at least 140 ml/kg for 48 hours or growing on less than 140 ml/kg/day for at least 48 hours; 3. Respiratory: apnea-free for at least 5 consecutive days. This outcome is censored at 48 weeks PMA
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of days to when out of incubator for 48 hours: when maintained stable temp for 48 hrs. This outcome is censored at 48 weeks PMA
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of days to apnea/ bradycardia free for 5 consecutive days. This outcome is censored at 48 weeks PMA
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The Number of Days to Oral Feeds >140 ml/kg/Day or Growing on Less Than 140 ml/kg/Day for at Least 48 Hours
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of days oral feeds >140 ml/kg/day or growing on less than 140 ml/kg/day for at least 48 hours. This outcome is censored at 48 weeks PMA
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Post-menstrual Age at Discharge
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The post-menstrual age of the infant at discharge censored at 48 weeks PMA and at time of transfer or death
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Weight Gain From Randomization Until Status
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Weight gain from randomization until status %(discharge up to 48 wks PMA, with censoring at time of transfer or death%).
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The Number of Days After Randomization Until Status That Infant Had at Least Two Consecutive Heart Rates >200 Documented at Least 3 Hours Apart
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of days after randomization until status that infant had at least two consecutive heart rates >200 documented at least 3 hours apart
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Treatment for High Blood Pressure
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Treatment for high blood pressure initiated after randomization until status.
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The Number of Episodes Between Randomization and Status That Infant Was Placed NPO for >= 24 Hours
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of episodes between randomization and status that infant was placed NPO for >= 24 hours
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Use of Anti-reflux Medications
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The use of anti-reflux medications started between randomization and status
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Number of Days That Significant Apnea/Bradycardia
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of days that significant apnea/bradycardia, as defined by documentation of infant receiving any of the following between randomization and status: open label caffeine, other methylxanthines, doxapram, CPAP or ventilatory support for apnea/bradycardia.
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
All-cause Mortality
Time Frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
All-cause mortality
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Number of All-cause Readmissions Within First 4 Weeks Post-discharge
Time Frame: Discharge through 4 weeks post-discharge
Number of all-cause readmissions within first 4 weeks post-discharge
Discharge through 4 weeks post-discharge
Number of All-cause Readmissions Within Second 4 Weeks Post-discharge
Time Frame: 4 weeks through 8 weeks post-discharge
Number of all-cause readmissions within second 4 weeks post-discharge
4 weeks through 8 weeks post-discharge
Number of All-cause Readmissions Within First 8 Weeks Post-discharge
Time Frame: Discharge through 8 weeks post-discharge
Number of all-cause readmissions within first 8 weeks post-discharge
Discharge through 8 weeks post-discharge
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 4 Weeks Post-discharge
Time Frame: Discharge through 4 weeks post-discharge
Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 4 weeks post-discharge
Discharge through 4 weeks post-discharge
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within Second 4 Weeks Post-discharge
Time Frame: 4 weeks through 8 weeks post-discharge
Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within second 4 weeks post-discharge
4 weeks through 8 weeks post-discharge
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 8 Weeks Post-discharge
Time Frame: Discharge through 8 weeks post-discharge
Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 8 weeks post-discharge
Discharge through 8 weeks post-discharge
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within Second 4 Weeks Post-discharge
Time Frame: 4 weeks through 8 weeks post-discharge
Number of sick visits related to apneic or apparent life-threatening events within second 4 weeks post-discharge
4 weeks through 8 weeks post-discharge
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 8 Weeks Post-discharge
Time Frame: Discharge through 8 weeks post-discharge
Number of sick visits related to apneic or apparent life-threatening events within first 8 weeks post-discharge
Discharge through 8 weeks post-discharge

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.
NICHD Neonatal Research Network

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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.
  • Principal Investigator: Waldemar Carlo, MD, University of Alabama at Birmingham

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.
February 27, 2019

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.
January 23, 2023

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 20, 2023

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).
November 3, 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.
November 8, 2017

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.
November 13, 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.
July 31, 2024

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.
July 30, 2024

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.
July 1, 2024

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.
  • NICHD-NRN-0056
  • UG1HD034216 (U.S. NIH Grant/Contract)
  • UG1HD027904 (U.S. NIH Grant/Contract)
  • UG1HD021364 (U.S. NIH Grant/Contract)
  • UG1HD027853 (U.S. NIH Grant/Contract)
  • UG1HD040689 (U.S. NIH Grant/Contract)
  • UG1HD040492 (U.S. NIH Grant/Contract)
  • UG1HD027851 (U.S. NIH Grant/Contract)
  • UG1HD087229 (U.S. NIH Grant/Contract)
  • UG1HD053109 (U.S. NIH Grant/Contract)
  • UG1HD068278 (U.S. NIH Grant/Contract)
  • UG1HD068244 (U.S. NIH Grant/Contract)
  • UG1HD068263 (U.S. NIH Grant/Contract)
  • UG1HD027880 (U.S. NIH Grant/Contract)
  • UG1HD053089 (U.S. NIH Grant/Contract)
  • UG1HD087226 (U.S. NIH Grant/Contract)
  • U10HD036790 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Per NIH Data Sharing Plan

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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