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

Primary Purpose

Apnea of Prematurity

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Caffeine Citrate
Placebo
Sponsored by
NICHD Neonatal Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apnea of Prematurity focused on measuring Moderate preterm infant, Caffeine citrate

Eligibility Criteria

29 Weeks - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Stanford University
  • Emory University
  • University of Iowa
  • University of New Mexico
  • University of Rochester
  • RTI International
  • Duke University
  • Cincinnati Children's Medical Center
  • Case Western Reserve University, Rainbow Babies and Children's Hospital
  • Research Institute at Nationwide Children's Hospital
  • University of Pennsylvania
  • Brown University, Women & Infants Hospital of Rhode Island
  • University of Texas Southwestern Medical Center at Dallas
  • University of Texas Health Science Center at Houston
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Caffeine Citrate

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of days of hospitalization
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.

Secondary Outcome Measures

The number of days to physiologic maturity after randomization
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.
PMA at discharge
Post menstrual age at discharge up to 48 wks PMA, censoring at time of transfer or death.
The number of all-cause hospital re-admissions
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.
The number of all-cause sick visits
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.
Death
All cause mortalities
Weight
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
Elevated Heart Rate
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
High Blood Pressure
Treatment for high blood pressure initiated after randomization until discharge up to 48 wks PMA, with censoring at time of transfer or death
Periods of NPO
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.
Reflux
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)
Significant Apnea
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)
Significant Bradycardia
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)
Arrhythmia
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
Seizures
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).

Full Information

First Posted
November 3, 2017
Last Updated
February 8, 2023
Sponsor
NICHD Neonatal Research Network
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03340727
Brief Title
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
Acronym
MoCHA
Official Title
Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NICHD Neonatal Research Network
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea of Prematurity
Keywords
Moderate preterm infant, Caffeine citrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Sample size for this trial will be flexible: the trial will be stopped for efficacy or futility based on pre-determined statistical thresholds or based on study drug availability.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caffeine Citrate
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Caffeine Citrate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of days of hospitalization
Description
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.
Time Frame
Randomization until discharge up to 48 wks PMA
Secondary Outcome Measure Information:
Title
The number of days to physiologic maturity after randomization
Description
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.
Time Frame
Randomization until physiologic maturity up to 48 wks PMA
Title
PMA at discharge
Description
Post menstrual age at discharge up to 48 wks PMA, censoring at time of transfer or death.
Time Frame
Randomization until discharge up to 48 wks PMA
Title
The number of all-cause hospital re-admissions
Description
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.
Time Frame
Discharge until eight weeks after discharge up to 52 wks PMA
Title
The number of all-cause sick visits
Description
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.
Time Frame
Discharge until eight weeks after discharge up to 52 wks PMA
Title
Death
Description
All cause mortalities
Time Frame
Randomization until eight weeks after discharge up to 52 wks PMA
Title
Weight
Description
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
Time Frame
Randomization until discharge up to 48 wks PMA
Title
Elevated Heart Rate
Description
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
Time Frame
Randomization until discharge up to 48 wks PMA
Title
High Blood Pressure
Description
Treatment for high blood pressure initiated after randomization until discharge up to 48 wks PMA, with censoring at time of transfer or death
Time Frame
Randomization until discharge up to 48 wks PMA
Title
Periods of NPO
Description
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.
Time Frame
Randomization until discharge up to 48 wks PMA
Title
Reflux
Description
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)
Time Frame
Randomization until discharge up to 48 wks PMA
Title
Significant Apnea
Description
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)
Time Frame
Randomization until discharge up to 48 wks PMA
Title
Significant Bradycardia
Description
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)
Time Frame
Randomization until discharge up to 48 wks PMA
Title
Arrhythmia
Description
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
Time Frame
Randomization until discharge up to 48 wks PMA
Title
Seizures
Description
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).
Time Frame
Randomization until discharge up to 48 wks PMA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waldemar Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
RTI International
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University, Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Research Institute at Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Brown University, Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Per NIH Data Sharing Plan

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

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