Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

NICHD Neonatal Research Network

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

Stanford Investigator(s):

Intervention(s):

  • Drug: Caffeine Citrate
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

29 Weeks - 33 Weeks

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Krisa P Van Meurs, MD
Not Recruiting