CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 256 enrolled
Drug / intervention
Indomethacin +3 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02221219
NCT02221219Phase 2Completed

Indomethacin and Delayed Umbilical Cord Clamp for Preterm Infant IVH

Hong Huang·interventional·Posted Aug 20, 2014·Updated Nov 23, 2021

In Brief

A Phase 2 clinical trial evaluating Indomethacin, delay in umbilical cord clamp at birth, and 2 other interventions for Intraventricular Hemorrhage and 3 related conditions. Completed, enrolled 256 participants across 1 site.

Detailed Summary

Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury and related disabilities later in life. Despite its prevalence, long term consequences, and enormous medical and social costs, mechanisms of IVH and optimal strategies to prevent or treat its occurrence are poorly defined, especially for extremely premature infants. Only one medical therapy, prophylactic indomethacin during the first 3 days of life, has been shown to prevent or decrease the severity of IVH in preterm infants, but its use is limited by toxic side effects and debatable effects on long-term outcomes. Several small studies and case reports suggest that delayed umbilical cord-clamping (DCC) may also decrease the incidence of IVH in premature infants, but thus far these trials have indomethacin treatment mixed within their cord clamping protocols. The investigators are conducting a randomized, blinded investigation of 4 treatment groups: 1) Control (no intervention); 2) DCC alone; 3) Prophylactic indomethacin alone; 4) Combination of DCC/indomethacin, with respect to survival, IVH or PVL incidence and severity, neurodevelopmental outcomes, and relevant mechanistic effects. With the steady rise in extreme prematurity births and clear links of IVH to long-term disabilities there is a need to improve care for these patients. This multi- disciplinary project addresses an important medical problem for an understudied patient population, where the current practice has clear limitations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 20, 2014
Enrollment StartAug 1, 2014
Primary CompletionOct 27, 2019
Study CompletionAug 28, 2021
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 11.9 years ago

Interventions

Indomethacindrug

indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants

delay in umbilical cord clamp at birthprocedure

provision of a \~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)

placebo infusiondrug

saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)

immediate cord clamp at birthprocedure

no delay in umbilical cord clamp; \<10sec (recorded in delivery note)