Share on facebook Share on Twitter Share on Google Plus Share This
Back to Results

The effect of rhCC10 on premature infants with RDS


Title Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome
Therapeutic Area Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant
Principal Investigator Jonathan Davis, MD
Min Age 0 Years
Max Age 1 Years
Gender Both
Contact Elyse Shenberger
(617) 636-7401
More Information https://clinicaltrials.gov/ct2/show/NCT01941745

Overview

The goal of this study is to assess the effectiveness of a new drug, rhCC10, on respiratory outcomes of premature infants with Respiratory Distress Syndrome.

Study Details

Inclusion Criteria

  • Infants less than or equal to 24 hours of life
  • Diagnosis of Respiratory Distress Syndrome with intubation
  • Received at least 1 dose of surfactant

Exclusion Criteria

  • Major congenital anomalies
  • 5 minute apgar score less than or equal to 5
  • Parents unable to return to hospital for follow-up visits after discharge

Study Requirements

The infants were given a dose of either the rhCC10 drug or a placebo and monitored closely via their medical record during their time in the hospital. After discharge, the families would receive a brief call from the study coordinator once per month to check in about the baby’s current health status and how they are breathing and doing. At 6, 12, and 18 months, the families would return to the follow-up clinic for a standard appointment at which time a longer interview was conducted with the parents. At 12 months, a small sample (4 uL) of blood was taken as well. Prior to the in-person visit, parents were asked to fill out a diary with questions about their child’s breathing for each day during the month leading up to the visit.