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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

Association between early echocardiographic parameters of hemodynamic significance and plasma NT pro-BNP and a composite outcome of death or postnatal morbidities by 36 weeks postmenstrual age in preterm neonates of 25-29 weeks gestation with echocardiographic evidence of patent ductus arteriosus: a prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/06/025812
Enrollment
162
Registered
2020-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public Contactsruthi nair

Fernandez hospital, Hyderabad

tejopratap@gmail.com9989372490

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026