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TerminatedNCT03340727MoCHAUpdated Jul 31, 2024Results posted

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

A Phase 3 interventional study of Caffeine Citrate and Placebo in Apnea of Prematurity, sponsored by NICHD Neonatal Research Network. Terminated at 16 sites in United States. Open to participants aged 29 Weeks to 33 Weeks. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by NICHD Neonatal Research Network · Phase 3, Interventional, and Treatment

Why this study was terminated
Futility
Phase
Phase 3
Study type
Interventional
Enrollment
827
Allocation
Randomized
Ages
29 Weeks to 33 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Apnea of Prematurity

Keywords

  • Moderate preterm infant
  • Caffeine citrate
03

Who can participate

Ages eligible
29 Weeks to 33 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
827 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugCaffeine 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.

  • DrugPlacebo

    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.

05

What researchers measure

Primary outcomes

  1. Number of Days Between Randomization and Hospital Discharge

    The number of days between randomization and hospital discharge. This outcome is censored at 48 weeks PMA and at time of transfer or death.

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  2. Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge

    Number of sick visits related to apneic or apparent life-threatening events within first 4 weeks post-discharge MEASTYPE=SEC

    Time frame: Discharge through 4 weeks post-discharge

Secondary outcomes

  1. The Number of Days to Physiologic Maturity After Randomization

    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

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  2. The Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs

    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

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  3. The Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days

    The number of days to apnea/ bradycardia free for 5 consecutive days. This outcome is censored at 48 weeks PMA

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  4. 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

    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

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  5. Post-menstrual Age at Discharge

    The post-menstrual age of the infant at discharge censored at 48 weeks PMA and at time of transfer or death

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  6. Weight Gain From Randomization Until Status

    Weight gain from randomization until status %(discharge up to 48 wks PMA, with censoring at time of transfer or death%).

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  7. The Number of Days After Randomization Until Status That Infant Had at Least Two Consecutive Heart Rates >200 Documented at Least 3 Hours Apart

    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

  8. Treatment for High Blood Pressure

    Treatment for high blood pressure initiated after randomization until status.

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  9. The Number of Episodes Between Randomization and Status That Infant Was Placed NPO for >= 24 Hours

    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

  10. Use of Anti-reflux Medications

    The use of anti-reflux medications started between randomization and status

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  11. Number of Days That Significant Apnea/Bradycardia

    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.

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  12. All-cause Mortality

    All-cause mortality

    Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

  13. Number of All-cause Readmissions Within First 4 Weeks Post-discharge

    Number of all-cause readmissions within first 4 weeks post-discharge

    Time frame: Discharge through 4 weeks post-discharge

  14. Number of All-cause Readmissions Within Second 4 Weeks Post-discharge

    Number of all-cause readmissions within second 4 weeks post-discharge

    Time frame: 4 weeks through 8 weeks post-discharge

  15. Number of All-cause Readmissions Within First 8 Weeks Post-discharge

    Number of all-cause readmissions within first 8 weeks post-discharge

    Time frame: Discharge through 8 weeks post-discharge

  16. Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 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

    Time frame: Discharge through 4 weeks post-discharge

  17. Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within Second 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

  18. Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 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

  19. Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within Second 4 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

  20. Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 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

06

Results

Posted Jun 28, 2024

Participant flow

Infants were recruited into the study based on eligibility and parental/guardian consent. Baseline characteristics of the mother were collected (with consent) for use in statistical analysis.

Participant flow — Overall Study
MilestoneCaffeine CitratePlacebo
Started416411
Completed in-hospital stay390397
Completed345351
Not completed7160
Withdrew: Death10
Withdrew: Lost to follow-up3135
Withdrew: Still in hospital at 48 0/7 wks post-menstrual age (pma)11
Withdrew: Transferred to another facility107
Withdrew: Withdrawal by subject2817

Outcome measures

PrimaryNumber of Days Between Randomization and Hospital Discharge

The number of days between randomization and hospital discharge. This outcome is censored at 48 weeks PMA and at time of transfer or death.

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Median · days
Number of Days Between Randomization and Hospital Discharge
daysCaffeinePlacebo
Number of Days Between Randomization and Hospital Discharge18 (10 to 30)16.5 (10 to 27)
SecondaryThe Number of Days to Physiologic Maturity After Randomization

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

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Median · days
The Number of Days to Physiologic Maturity After Randomization
daysCaffeinePlacebo
The Number of Days to Physiologic Maturity After Randomization13 (7 to 23)14 (8 to 23)
SecondaryThe Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs

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

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Median · days
The Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs
daysCaffeinePlacebo
The Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs5 (2 to 9)5 (1 to 9)
SecondaryThe Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days

The number of days to apnea/ bradycardia free for 5 consecutive days. This outcome is censored at 48 weeks PMA

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Median · days
The Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days
daysCaffeinePlacebo
The Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days8 (5 to 16)11 (5 to 18)
SecondaryThe Number of Days to Oral Feeds >140 ml/kg/Day or Growing on Less Than 140 ml/kg/Day for at Least 48 Hours

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

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Median · days
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
daysCaffeinePlacebo
The Number of Days to Oral Feeds >140 ml/kg/Day or Growing on Less Than 140 ml/kg/Day for at Least 48 Hours14 (6 to 23)12 (5 to 22)
SecondaryPost-menstrual Age at Discharge

The post-menstrual age of the infant at discharge censored at 48 weeks PMA and at time of transfer or death

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Mean · weeks
Post-menstrual Age at Discharge
weeksCaffeinePlacebo
Post-menstrual Age at Discharge37.7 (37.5 to 37.9)37.6 (37.4 to 37.8)
SecondaryWeight Gain From Randomization Until Status

Weight gain from randomization until status %(discharge up to 48 wks PMA, with censoring at time of transfer or death%).

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Mean · grams per day
Weight Gain From Randomization Until Status
grams per dayCaffeinePlacebo
Weight Gain From Randomization Until Status28.9 (28.1 to 29.8)32.2 (30.9 to 33.4)
SecondaryThe Number of Days After Randomization Until Status That Infant Had at Least Two Consecutive Heart Rates >200 Documented at Least 3 Hours Apart

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
Reported as:
Median · days
The Number of Days After Randomization Until Status That Infant Had at Least Two Consecutive Heart Rates >200 Documented at Least 3 Hours Apart
daysCaffeinePlacebo
The Number of Days After Randomization Until Status That Infant Had at Least Two Consecutive Heart Rates >200 Documented at Least 3 Hours Apart0 (0 to 0)0 (0 to 0)
SecondaryTreatment for High Blood Pressure

Treatment for high blood pressure initiated after randomization until status.

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Count of participants · Participants
Treatment for High Blood Pressure
ParticipantsCaffeinePlacebo
No412410
Yes21
SecondaryThe Number of Episodes Between Randomization and Status That Infant Was Placed NPO for >= 24 Hours

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
Reported as:
Median · episodes
The Number of Episodes Between Randomization and Status That Infant Was Placed NPO for >= 24 Hours
episodesCaffeinePlacebo
The Number of Episodes Between Randomization and Status That Infant Was Placed NPO for >= 24 Hours0 (0 to 0)0 (0 to 0)
SecondaryUse of Anti-reflux Medications

The use of anti-reflux medications started between randomization and status

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Count of participants · Participants
Use of Anti-reflux Medications
ParticipantsCaffeinePlacebo
No384387
Yes3024
SecondaryNumber of Days That Significant Apnea/Bradycardia

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.

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Median · days
Number of Days That Significant Apnea/Bradycardia
daysCaffeinePlacebo
Number of Days That Significant Apnea/Bradycardia0 (0 to 0)0 (0 to 0)
SecondaryAll-cause Mortality

All-cause mortality

Time frame:
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Reported as:
Count of participants · Participants
All-cause Mortality
ParticipantsCaffeinePlacebo
No415411
Yes10
SecondaryNumber of All-cause Readmissions Within First 4 Weeks Post-discharge

Number of all-cause readmissions within first 4 weeks post-discharge

Time frame:
Discharge through 4 weeks post-discharge
Reported as:
Median · count of readmissions
Number of All-cause Readmissions Within First 4 Weeks Post-discharge
count of readmissionsCaffeinePlacebo
Number of All-cause Readmissions Within First 4 Weeks Post-discharge0 (0 to 0)0 (0 to 0)
SecondaryNumber of All-cause Readmissions Within Second 4 Weeks Post-discharge

Number of all-cause readmissions within second 4 weeks post-discharge

Time frame:
4 weeks through 8 weeks post-discharge
Reported as:
Median · count of readmissions
Number of All-cause Readmissions Within Second 4 Weeks Post-discharge
count of readmissionsCaffeinePlacebo
Number of All-cause Readmissions Within Second 4 Weeks Post-discharge0 (0 to 0)0 (0 to 0)
SecondaryNumber of All-cause Readmissions Within First 8 Weeks Post-discharge

Number of all-cause readmissions within first 8 weeks post-discharge

Time frame:
Discharge through 8 weeks post-discharge
Reported as:
Median · count of readmissions
Number of All-cause Readmissions Within First 8 Weeks Post-discharge
count of readmissionsCaffeinePlacebo
Number of All-cause Readmissions Within First 8 Weeks Post-discharge0 (0 to 0)0 (0 to 0)
SecondaryNumber of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 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

Time frame:
Discharge through 4 weeks post-discharge
Reported as:
Median · count of sick visits
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 4 Weeks Post-discharge
count of sick visitsCaffeinePlacebo
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 4 Weeks Post-discharge0 (0 to 0)0 (0 to 0)
SecondaryNumber of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within Second 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
Reported as:
Median · count of sick visits
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within Second 4 Weeks Post-discharge
count of sick visitsCaffeinePlacebo
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within Second 4 Weeks Post-discharge0 (0 to 0)0 (0 to 0)
SecondaryNumber of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 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
Reported as:
Median · count of sick visits
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 8 Weeks Post-discharge
count of sick visitsCaffeinePlacebo
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 8 Weeks Post-discharge0 (0 to 0)0 (0 to 0)
PrimaryNumber of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge

Number of sick visits related to apneic or apparent life-threatening events within first 4 weeks post-discharge MEASTYPE=SEC

Time frame:
Discharge through 4 weeks post-discharge
Reported as:
Median · count of apnea visits
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge
count of apnea visitsCaffeinePlacebo
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge0 (0 to 0)0 (0 to 0)
SecondaryNumber of Sick Visits Related to Apneic or Apparent Life-threatening Events Within Second 4 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
Reported as:
Median · count of apnea visits
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within Second 4 Weeks Post-discharge
count of apnea visitsCaffeinePlacebo
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within Second 4 Weeks Post-discharge0 (0 to 0)0 (0 to 0)
SecondaryNumber of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 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
Reported as:
Median · count of apnea visits
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 8 Weeks Post-discharge
count of apnea visitsCaffeinePlacebo
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 8 Weeks Post-discharge0 (0 to 0)0 (0 to 0)

Adverse events

Collected over Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.. Non-serious events are listed at a 0.00% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Caffeine1/416 (0.2%)12/416 (2.9%)10/416 (2.4%)
Placebo0/411 (0%)22/411 (5.4%)24/411 (5.8%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventCaffeinePlacebo
Apnea neonatalRespiratory, thoracic and mediastinal disorders2/4169/411
VomitingGastrointestinal disorders0/4164/411
Necrotising enterocolitis neonatalGastrointestinal disorders0/4162/411
BronchiolitisInfections and infestations1/4162/411
Rhinovirus infectionInfections and infestations1/4162/411
Sepsis neonatalInfections and infestations1/4162/411
Respiratory syncytial virus infectionInfections and infestations2/4161/411
Neonatal tachycardiaCardiac disorders0/4161/411
Gastrooesophageal reflux diseaseGastrointestinal disorders0/4161/411
Ileal stenosisGastrointestinal disorders0/4161/411
Most frequent other events
Most frequent other events
EventCaffeinePlacebo
Hypertension neonatalVascular disorders9/41610/411
Apnea neonatalRespiratory, thoracic and mediastinal disorders1/4169/411
Necrotising enterocolitis neonatalGastrointestinal disorders0/4162/411
Sepsis neonatalInfections and infestations0/4162/411
HaematocheziaGastrointestinal disorders0/4161/411
Arrhythmia neonatalCardiac disorders1/4160/411

Baseline characteristics

The study recruited infants based on eligibility and parental/guardian consent. Baseline characteristics of the mother were collected (with consent) for use in statistical analysis.

Age, Continuous
Age, Continuous(years)CaffeinePlaceboTotal
Mean30 ± 5.829.9 ± 5.829.9 ± 5.8
Sex/Gender, Customized
Sex/Gender, Customized(Participants)CaffeinePlaceboTotal
Female213207420
Male203204407
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)CaffeinePlaceboTotal
American Indian or Alaskan Native71219
Asian12921
Black110110220
More Than One Race325
Native Hawaiian or Other Pacific Islander448
Unknown224
Unknown or Not Reported131124
White265261526
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)CaffeinePlaceboTotal
Hispanic or Latino6354117
Not Hispanic or Latino338345683
Unknown224
Unknown or Not Reported131023
Marital status
Marital status(Participants)CaffeinePlaceboTotal
Married213233446
Single200175375
Unknown336
Mothers education, Customized
Mothers education, Customized(Participants)CaffeinePlaceboTotal
8th grade or less9514
9th to 12th grade332255
College degree6875143
Graduate degree383876
High School degree86102188
Partial college/Associate degree9390183
Trade or technical school101020
Unknown7969148
Mothers insurance, Customized
Mothers insurance, Customized(Participants)CaffeinePlaceboTotal
Private207213420
Public203190393
Self-pay/uninsured6713
Unknown011
Gravidity
Gravidity(years)CaffeinePlaceboTotal
Median2.5 (1 to 4)2 (1 to 4)2 (1 to 4)

11 further baseline measures are reported on the registry.

07

Study locations

16 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
  • Stanford University
    Palo Alto, California 94304, United States
  • Emory University
    Atlanta, Georgia 30303, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • University of New Mexico
    Albuquerque, New Mexico 87131, United States
  • University of Rochester
    Rochester, New York 14642, United States
  • RTI International
    Durham, North Carolina 27705, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • Cincinnati Children's Medical Center
    Cincinnati, Ohio 45267, United States
  • Case Western Reserve University, Rainbow Babies and Children's Hospital
    Cleveland, Ohio 44106, United States
  • Research Institute at Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Brown University, Women & Infants Hospital of Rhode Island
    Providence, Rhode Island 02905, United States
  • University of Texas Southwestern Medical Center at Dallas
    Dallas, Texas 75235, United States
  • University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • University of Utah
    Salt Lake City, Utah 84108, United States
08

References and documents

Study documents

  • Study protocol · Dec 16, 2021
  • Statistical analysis plan · Dec 12, 2022
  • Informed consent form · Dec 16, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Per NIH Data Sharing Plan

09

Registry details

Key details

Study ID
NCT03340727
Lead sponsor
NICHD Neonatal Research Network
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Nov 13, 2017
Start date
Feb 27, 2019
Primary completion
Jan 23, 2023
Completion
Mar 20, 2023
Results posted
Jun 28, 2024
Last update
Jul 31, 2024

Study contacts

Waldemar Carlo, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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