Clinical RD (Respiratory Distress) Score for Objective Decision Making for Surfactant Therapy

NCT03273764 | Completed DMC

• 1 other identifier: LadyHardingeMedicalCollege
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

To develop a comprehensive 'Clinical RD score' for decision making for administration of Surfactant in respiratory distress syndrome in preterm infants with gestation of 26 0/7 - 34 6/7 weeks and to assess the validity of this 'clinical RD score' on a different subgroup of patients with similar gestational age.

Conditions

Respiratory Distress Syndrome in Premature Infant; Surfactant; CPAP

Keywords

Preterm, RDS, Surfactant, CPAP

Outcome Measures

Primary Outcomes (1)

• Developement of a clinical RD score for decision making for administration of surfactant in preterm babies with RDS

  The study will be conducted in 2 parts.Written informed consent will be obtained from one of the parents of the eligible neonates. The demographic and clinical data related to all putative risk factors will be recorded at the time of enrollment from all eligible neonates in the age group of 26-34 weeks with clinical features suggestive of RDS/HMD (Hyaline Membrane Disease). The putative risk factors which could potentially increase the chances of surfactant administration to the infant will be documented and will be analysed through logistic regression analysis and clinical RD score will be developed. The score developed in the first part of the study will be applied on a different population of preterm infants with RDS with similar gestational age.

  January 2015 to September 2016

Study Arms (1)

Preterm neonates with RDS

Singleton Preterm neonates with gestational age between 26 completed weeks to 34 completed weeks with clinical diagnosis of RDS without any major congenital anomalies.

Eligibility Criteria

• Age: 26 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm neonates between 26 weeks to 34 weeks of gestation with a clinical diagnosis of RDS.

You may not qualify if:

• Major congenital malformation
• Antenatally diagnosed congenital heart disease in fetus.
• Hydrops fetalis
• Massive Pulmonary hemorrhage prior to enrolment
• Shock requiring vasopressor support prior to enrolment
• Non availability of CPAP/ventilator in the unit.

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Lady Hardinge Medical college

New Delhi, National Capital Territory of Delhi, 110001, India

Location

MeSH Terms

Conditions

Premature Birth; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sushma Nangia, MBBS, MD, DM

  Kalawati Saran Chindren Hospital and Lady Hardinge Medical College

  PRINCIPAL INVESTIGATOR

• Debasish Nanda, MBBS, MD

  Kalawati Saran Chindren Hospital and Lady Hardinge Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director professor and head of department

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 6, 2017
• Study Start: January 1, 2015
• Primary Completion: September 30, 2016
• Study Completion: December 23, 2016
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

IN (1)