Association of Patent ductus arteriosus of hemodynamic sugnificance with plasma NT pro BNP level and study of outcomes of death and morbidities at 36 weeks in neonates of gestational age 25-29 weeks

Not Applicable

• Conditions: Health Condition 1: I00-I99- Diseases of the circulatory system

• Registration Number: CTRI/2020/06/025812
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Neonates born in the unit between 25 to 29 weeks and 6 days will be eligible for inclusion

Exclusion Criteria

1. Antenatally suspected or proven congenital heart disease

2. Suspected congenital heart disease (other than PDA) on the first screening postnatal

echocardiography (would be however

included if proven as normal by a Pediatric

cardiologist before the echo done on

day 2)

3. Major or life threatening congenital

malformation

4. Suspected congenital rubella infection based on the maternal positive serology for IgM

rubella antibodies anytime during the

current pregnancy

5. PDA that did not remain open beyond 24 hours of age as well as did not cause a PDA ssociated acute hemodynamic worsening in the first

24 hours of life

All consecutively inborn neonates in the gestational age of 25 to 29 6/7 weeks would be

screened with Portable Ultrasound Machine between 12-24 hours of life for presence of

patent ductus arteriosus with pure

or predominant left to right shunt

across the ductus arteriosus as

per the unit policy.

Is the subject

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite outcome of: <br/ ><br>Mortality, Bronchopulmonary dysplasia, Retinopathy of prematurity requiring laser therapy, advanced Necrotising Enterocolitis(stage 2A), Major Intraventricular <br/ ><br>hemorrhage (grade 3 and above), Periventricular <br/ ><br>leukomalaciaTimepoint: 36 weeks of corrected age or at discharge whichever is earlier

Secondary Outcome Measures

Name	Time	Method
1) PDA associated acute worsening by discharge <br/ ><br>2)Mortality before 14 days of life <br/ ><br>3) Mortality, bronchopulmonary dysplasia, retinopathy of prematurity requiring laser, advanced necrotising enterocolitis(stage 2A), Major intraventricular <br/ ><br>haemorrhage (grade 3 and <br/ ><br>above), periventricular leukomalaciaTimepoint: 36 weeks postmenstrual age