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

NICHD Neonatal Research Network

Status and phase: Terminated; Phase 3

Conditions: Apnea of Prematurity

Treatments: Drug: Caffeine Citrate; Drug: Placebo

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT03340727

UG1HD040689 (U.S. NIH Grant/Contract)

NICHD-NRN-0056

UG1HD021364 (U.S. NIH Grant/Contract)

UG1HD040492 (U.S. NIH Grant/Contract)

UG1HD027904 (U.S. NIH Grant/Contract)

UG1HD053089 (U.S. NIH Grant/Contract)

U10HD036790 (U.S. NIH Grant/Contract)

UG1HD034216 (U.S. NIH Grant/Contract)

UG1HD068244 (U.S. NIH Grant/Contract)

UG1HD027851 (U.S. NIH Grant/Contract)

UG1HD027853 (U.S. NIH Grant/Contract)

UG1HD068278 (U.S. NIH Grant/Contract)

UG1HD087226 (U.S. NIH Grant/Contract)

UG1HD027880 (U.S. NIH Grant/Contract)

UG1HD068263 (U.S. NIH Grant/Contract)

UG1HD087229 (U.S. NIH Grant/Contract)

UG1HD053109 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 827 patients

Sex: All

Ages: 29 to 33 weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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827 participants in 2 patient groups, including a placebo group

Caffeine Citrate

Experimental group

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.

Treatment:

Drug: Caffeine Citrate

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo