Randomized Controlled Trial of Home Therapy with Caffeine Citrate in Moderately Preterm Infants with Apnea of Prematurity

  • STATUS
    Recruiting
  • participants needed
    80
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Updated on 19 February 2024

Summary

This trial evaluates 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. It is a randomized, double-blinded, placebo-controlled, multicenter trial. The primary outcome of the study will be the number of days of hospitalization from randomization to discharge up to 48 weeks post-menstrual age (PMA), with censoring at time of transfer or death. The eligibility criteria for the study are inborn and outborn infants of 29 0/7 to 33 6/7 weeks gestational age at birth admitted to hospitals of the National Institute of Child Health and Human Development Neonatal Research Network (NRN) less than or equal to 72 hours of age and who at time of enrollment are less than or equal to 35 6/7 weeks post-menstrual age at the time of randomization and receiving caffeine with plan to discontinue treatment or just discontinued caffeine treatment.

Description


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Condition infant,apnea
Age 99years or below
Clinical Study Identifier03340727
Last Modified on19 February 2024

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