Summary

at UCLA
study started
estimated completion
Uday Devaskar(ucla)

Description

Summary

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.

Official Title

A Randomized Controlled Trial of the Effect Of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22 - 26 Months of Age in Intubated Infants < 30 Weeks Gestation Age

Details

Bronchopulmonary dysplasia (BPD) remains a leading morbidity of the extremely preterm infant, and prolonged mechanical ventilation is associated with increased risk for BPD. Dexamethasone has been used previously to facilitate extubation and decrease the incidence of BPD; however, due to adverse effects on neurodevelopmental outcomes, the use of this drug has decreased. One cohort study suggests that hydrocortisone (HC) may facilitate extubation. HC has thus far not been associated with adverse neurodevelopmental outcomes in either cohort studies or randomized controlled trials. A recent meta-analysis of postnatal corticosteroid therapy begun after the first week of life suggested that "late therapy may reduce neonatal mortality without significantly increasing the risk of adverse long-term neurodevelopmental outcomes," although the methodological quality of some of the follow-up was acknowledged to be limited.

This is a randomized controlled trial to study the efficacy and safety of a 10-day tapering course of hydrocortisone treatment for infants <30 weeks estimated gestational age at birth who remain intubated at 14 - 28 days postnatal age. Based on previous Network data these criteria define a population with a risk of death or BPD at 36 weeks postmenstrual age of approximately 65 - 75%. The primary outcome for this study will incorporate both (1) survival without moderate to severe BPD by Network physiologic definition and (2) survival without moderate or severe NDI at 18 - 22 months corrected age. Therefore, the results of this study will be reported only when follow-up data are available unless (1) the trial is stopped early by the DSMC because of strong evidence of benefit or harm, or (2) at the time all subjects have completed treatment the DCC finds a substantial survival benefit favoring hydrocortisone (p<0.001). Individual study assignment will remain masked until the follow-up is completed. Secondary outcomes will include short term measures such as respiratory morbidities and growth at 36 weeks postmenstrual age and long term measures including growth and other outcomes at 22 - 26 months corrected age.

Secondary studies include:

1)Effect of Hydrocortisone on the Cardiac mass of Premature Intubated Infants - will determine left ventricular mass index at 36 weeks postmenstrual age (or prior to discharge/transfer if after 34 weeks) in infants enrolled in the hydrocortisone for BPD RCT, and compare HC-treated infants to placebo-treated infants. It will similarly assess and compare the incidence of pulmonary hypertension in these patients.

Extended follow-up: Subjects will be seen for a follow-up visit at 5-6 years corrected age to assess functional developmental and respiratory outcomes at early school age. In a subset of four Neonatal Research Network Clinical Centers, impulse oscillometry (IOS), which is the optimal direct measure of lung capacity and function, will be performed to validate the 6-minute walk test and International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire as functional measures of pulmonary status.

Keywords

Infant, Newborn Infant, Small for Gestational Age Infant, Very Low Birth Weight Infant, Premature Bronchopulmonary Dysplasia NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Very Low Birth Weight (VLBW) Prematurity Mechanical ventilation Intubation Neurodevelopmental impairment Birth Weight Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate

Eligibility

You can join if…

  • infants <30 weeks estimated gestational age
  • inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age
  • have received at least 7days of mechanical ventilation;
  • are receiving mechanical ventilation through an endotracheal tube .

You CAN'T join if...

  • Major congenital anomalies
  • Decision to limit support
  • Indomethacin or ibuprofen treatment within 48 hours of study drug
  • Previous corticosteroid treatment for BPD
  • Received hydrocortisone for 14 or more cumulative days
  • Received hydrocortisone within 7 days of study entry

Locations

  • University of California - Los Angeles
    Los Angeles California 90025 United States
  • Stanford University
    Palo Alto California 94304 United States

Lead Scientist

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NICHD Neonatal Research Network
Links
NICHD Neonatal Research Network site
NICHD Pregnancy & Perinatology Branch
ID
NCT01353313
Phase
Phase 3
Study Type
Interventional
Last Updated