CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 525 enrolled
Drug / intervention
Nutrientdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00828243
NCT00828243N/ACompleted
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Genetic Regulation of Surfactant Deficiency in Human Newborn Infants

Washington University School of Medicine·observational·Posted Jan 23, 2009·Updated Jun 7, 2021

In Brief

An observational study evaluating Nutrient for Respiratory Distress Syndrome, Newborn. Completed, enrolled 525 participants across 1 site.

Detailed Summary

Inherited deficiencies in any one of 3 genes (surfactant protein B, surfactant protein C, and ATP-binding cassette transporter A3) can cause neonatal respiratory distress syndrome by disrupting metabolism of the pulmonary surfactant. The investigators will use state of the art methods to link specific changes in the genetic code of each of these genes with disruption of discrete steps in the metabolism of the pulmonary surfactant in human newborn infants. These studies will lead to improved diagnostic capabilities and suggest novel strategies to correct surfactant deficiency in newborn infants.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Distress Syndrome, Newborn
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 23, 2009
Enrollment StartNov 1, 2007
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.4 years ago

Interventions

Nutrientdrug

We administer stable isotopically labeled precursors of surfactant phospholipids (\[1-13C1\] acetate) and of surfactant protein-B (\[5,5,5-2H3\] leucine) to infants with neonatal respiratory distress syndrome. Using mass spectrometry, we measure incorporation of stable isotopically labeled precursors in tracheal aspirates and compare surfactant phospholipid and surfactant protein-B turnover.