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

February 8, 2023 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

800

Phase

  • 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 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

Ages Eligible for Study

6 months to 7 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
Number of days of hospitalization
Time Frame: Randomization until discharge up to 48 wks PMA
The number of days of hospitalization from randomization to discharge up to 48 weeks postmentrual age (PMA), with censoring at time of transfer or death.
Randomization until discharge up to 48 wks PMA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of days to physiologic maturity after randomization
Time Frame: Randomization until physiologic maturity up to 48 wks PMA
Physiologic maturity is defined as: 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/day or growing on less than 140 ml/kg/day for at least 48 hours and 3) Respiratory: apnea-free for at least 5 days. The number of days to physiologic maturity after randomization up to 48 wks PMA, with censoring at time of transfer or death.
Randomization until physiologic maturity up to 48 wks PMA
PMA at discharge
Time Frame: Randomization until discharge up to 48 wks PMA
Post menstrual age at discharge up to 48 wks PMA, censoring at time of transfer or death.
Randomization until discharge up to 48 wks PMA
The number of all-cause hospital re-admissions
Time Frame: Discharge until eight weeks after discharge up to 52 wks PMA
The number of all-cause re-admissions to the hospital within the first four weeks, second four weeks, and first eight weeks combined among those discharged from the hospital by 48 wks PMA.
Discharge until eight weeks after discharge up to 52 wks PMA
The number of all-cause sick visits
Time Frame: Discharge until eight weeks after discharge up to 52 wks PMA
The number of all-cause sick visits to urgent care, emergency rooms, or health care provider's office within the first four weeks, second four weeks, and first eight weeks combined among those discharged from the hospital by 48 wks PMA.
Discharge until eight weeks after discharge up to 52 wks PMA
Death
Time Frame: Randomization until eight weeks after discharge up to 52 wks PMA
All cause mortalities
Randomization until eight weeks after discharge up to 52 wks PMA
Weight
Time Frame: Randomization until discharge up to 48 wks PMA
Weight will be recorded at time of of birth, randomization and at status: discharge up to 48 wks PMA ,with censoring at time of transfer or death
Randomization until discharge up to 48 wks PMA
Elevated Heart Rate
Time Frame: Randomization until discharge up to 48 wks PMA
The number of days after randomization that infant had at least two consecutive heart rates >200 documented at least 3 hours apart (when infant not crying) until discharge up to 48 wks PMA, with censoring at time of transfer or death
Randomization until discharge up to 48 wks PMA
High Blood Pressure
Time Frame: Randomization until discharge up to 48 wks PMA
Treatment for high blood pressure initiated after randomization until discharge up to 48 wks PMA, with censoring at time of transfer or death
Randomization until discharge up to 48 wks PMA
Periods of NPO
Time Frame: Randomization until discharge up to 48 wks PMA
The number of episodes between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death) that infant was placed NPO for ≥ 24 hours.
Randomization until discharge up to 48 wks PMA
Reflux
Time Frame: Randomization until discharge up to 48 wks PMA
The use of anti-reflux medications started between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death)
Randomization until discharge up to 48 wks PMA
Significant Apnea
Time Frame: Randomization until discharge up to 48 wks PMA
The number of days that significant apnea, as defined by receiving open label caffeine, CPAP for apnea or ventilatory support for apnea, is documented between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death)
Randomization until discharge up to 48 wks PMA
Significant Bradycardia
Time Frame: Randomization until discharge up to 48 wks PMA
The number of days that significant bradycardia, as defined by receiving treatment, is documented between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death)
Randomization until discharge up to 48 wks PMA
Arrhythmia
Time Frame: Randomization until discharge up to 48 wks PMA
The presence of documented and treated arrhythmias between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death), not due to tachycardia or bradycardia
Randomization until discharge up to 48 wks PMA
Seizures
Time Frame: Randomization until discharge up to 48 wks PMA
The onset of documented seizures, as defined by treating with anti-convulsants, between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death).
Randomization until discharge up to 48 wks PMA

Collaborators and Investigators

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

Sponsor

NICHD Neonatal Research Network

Collaborators

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

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)

February 27, 2019

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (ACTUAL)

November 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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