An observervational study to predict if baby will require respiratory support at 28 days of life using lung ultrasound in babies born less than 32 weeks of gestational age

Not yet recruiting

• Conditions: Bronchopulmonary dysplasia originating in the perinatal period,

• Registration Number: CTRI/2023/11/059483
• Lead Sponsor: Bharati Vidyapeeth Medical college

Brief Summary

This prospective observational study is being taken up to predict the need of respiratory support at 28 days of life using point-of-care lung ultrasound scores in preterm neonates less than 32 weeks of gestational age. We hypothesize that since the LUS score reflects lung aeration, it will correlate with the need of respiratory support at 28 days of life. This can not only help in early prediction and intervention thus preventing respiratory morbidities but also in the counseling of parents about prognosis, financial burden, and follow-up respiratory care.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-31
• Study Start: 2023-11-11

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

All newborns less than 32 weeks of gestational age will be recruited.

Exclusion Criteria

• Major congenital malformation (cyanotic congenital heart disease, suspected genetic disorders, structural diseases affecting lung function (congenital diaphragmatic hernia).
• Suspected Inborn errors of metabolism 3.
• Extramural preterm babies admitted in the unit after 24 hours of birth 4.
• Suspected muscular dystrophy or neurological disease that may affect lung development or function.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To predict the need of respiratory support at 28 days of life using lung ultrasound score at 7 days of life in preterm neonates less than 32 weeks of gestational age	7 & 28 days

Secondary Outcome Measures

Name	Time	Method
To determine the association of the score on day 7 with the type of respiratory support required at 28 days of life	7 & 28 days
To determine the association of the score on day 14 with the type of respiratory support required at 28 days of life	14 & 28 days

Trial Locations

Locations (1)

Bharati vidyapeeth deemed to be university medical college and hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Bharati vidyapeeth deemed to be university medical college and hospital, Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Vikrant Deshmukh

Principal investigator

9096015474

vikrant.deshmukh40@gmail.com