FindTrial
Sign In

Using Lung Ultrasound to Guide Surfactant Treatment in Premature Babies with Breathing Problems: A Comparison with Standard Care

Efficacy of Surfactant Administration Guided by Lung Ultrasound Score versus Conventional Parameters in Neonates less than 32 weeks Gestational Age with Respiratory Distress Syndrome: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098370
Enrollment
66
Registered
2025-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: J988- Other specified respiratory disorders

Interventions

Intervention1: Experimental Arm: Neonates in experimental arm would be evaluated for Lung ultrasound score at arrival to NICU and if the Lung ultrasound score is more than 8, surfactant will be admini

Sponsors

Dr Manoj Modi
Lead Sponsor
Dr Sujay R
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Male and female neonates less than 32 weeks of gestational age with Respiratory Distress Syndrome

Exclusion criteria

Exclusion criteria: Endotracheal intubation in the delivery room, APGAR less than or equal to 3 at 5 minutes, Major congenital malformations, Parental refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
Time to first dose of surfactant administrationTimepoint: nil—

Secondary

MeasureTime frame
Need for mechanical ventilation at 24 hrs of lifeTimepoint: at 24 hours of life;Proportion of neonates requiring surfactant in each groupTimepoint: nil;Cumulative doses of surfactantTimepoint: nil;Oxygenation index or oxygen saturation index and FiO2 over first 24 hrs of lifeTimepoint: first 24 hours of life;Duration of respiratory support including both invasive and non-invasive ventilationTimepoint: till discharge or death in NICU;Air leaksTimepoint: till discharge or death in NICU;SepsisTimepoint: till discharge or death in NICU;Necrotizing enterocolitis stage 2 or moreTimepoint: till discharge or death in NICU;Intraventricular haemorrhage IVH grade 3 or 4Timepoint: till discharge or death in NICU;Periventricular leukomalacia grade 3 or 4Timepoint: till discharge or death in NICU;Bronchopulmonary dysplasia at 36 weeks PMATimepoint: at 36 weeks of post menstrual age;Retinopathy of prematurity requiring treatmentTimepoint: till discharge or death in NICU;Abnormal neurological examination at dischargeTimepoint: at discharge;Length of NICU stayTimepoint: till discharge or daeth in NICU;MortalityTimepoint: before discharge;Composite outcome includes Death or severe morbidities like Incidence of NEC stage more than or equal to 2, IVH grade 3 or 4, PVL grade 3 or 4, Moderate tonsevere BPD, ROP requiring treatment.Timepoint: till discharge or death in NICU—

Countries

India

Contacts

Public ContactDr Sujay R

Sir Ganga Ram Hospital

drmanojmodi@gmail.com9873266331

Outcome results

None listed

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