To compare the outcomes of neonates who received surfactant for breathing difficulty with neonates who did not, in an advanced neonatal care unit in South India.

Not yet recruiting

Conditions: Preterm [premature] newborn [other],

Registration Number: CTRI/2022/05/042379

Lead Sponsor: Riya Asokan

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 52

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the mortality rate of preterm infants who received surfactant with infants who did not receive surfactant.	The outcomes will be assessed at the time of discharge / death. (However, all the date are collected retrospectively)

Secondary Outcome Measures

Name	Time	Method
To evaluate the following outcomes :	The major morbidities (ROP, BPD, IVH)

Trial Locations

Locations (1): Neonatal Intensive Care Unit
🇮🇳
Ernakulam, KERALA, India
Neonatal Intensive Care Unit
🇮🇳Ernakulam, KERALA, India
Riya Asokan
Principal investigator
8606446072
riyaasok@gmail.com