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Clinical Trials/CTRI/2022/05/042379
CTRI/2022/05/042379Not yet recruitingNot Applicable

Influence of surfactant administration on neonatal outcomes in a tertiary care neonatal unit in South India

Riya Asokan1 site in 1 country52 target enrollmentStarted: October 5, 2022Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
52
Locations
1
Primary Endpoint
To compare the mortality rate of preterm infants who received surfactant with infants who did not receive surfactant.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This Study is a retrospective cross-sectional study to determine the influence of surfactant therapy in preterm neonates .Patients were dividedinto two groups: no surfactant and single (or) multiple doses. Decision to administer surfactant was based on established diagnostic criteria for

RDS adapted to a resource limited setting. The primary outcome was a composite of mortality and any of the major morbidities, including IVH

(grade 3 or 4), bronchopulmonary dysplasia or retinopathy of prematurity.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Day(s) to 30.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • •All inborn neonates with respiratory distress born between 23-34 weeks.

Exclusion Criteria

  • •Newborns >34 weeks gestation at birth All out born babies Infants who received surfactant for indications other than RDS (Eg; Pulmonary hemorrhage, Meconium aspiration) Infants with fatal congenital anomalies.

Outcomes

Primary Outcomes

To compare the mortality rate of preterm infants who received surfactant with infants who did not receive surfactant.

Time Frame: The outcomes will be assessed at the time of discharge / death. (However, all the date are collected retrospectively)

Secondary Outcomes

  • To evaluate the following outcomes :(The major morbidities (ROP, BPD, IVH))

Investigators

Sponsor
Riya Asokan
Sponsor Class
Other [self]

Study Sites (1)

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