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A study aimed at determining if lung ultrasound allows for faster administration of surfactant when compared to standard clinical criteria in babies born before 34 weeks of gestation with breathing difficulty

Clinical versus lung ultrasound score-based criteria for guiding surfactant replacement therapy in RDS in neonates less than 34 weeks-A randomised controlled trial - CLUSTER (Clinical versus Lung Ultrasound in guiding Surfactant ThERapy)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/111908
Enrollment
72
Registered
2026-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: Lung Ultrasound performed within 1 hour of birth: Lung Ultrasound Score (LUS)-guided surfactant administration. To determine if Surfactant replacement therapy can be initiated early bas

Sponsors

Dr Rajesh R N
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Babies born below 34 weeks of gestation at AIIMS, Nagpur 2.Babies with RDS, defined as distress appearing within first 24 hours of life which requires nCPAP / ventilation to maintain a saturation of above 90%

Exclusion criteria

Exclusion criteria: 1.Non-acceptance of the informed consent 2.Major congenital malformations 3.Signs of early-onset septic shock 4.Babies receiving surfactant in the delivery room as part of advanced resuscitation

Design outcomes

Primary

MeasureTime frame
The mean time to surfactant administration in each group, and the study will assess whether the difference in mean times between the two groups is statistically significantTimepoint: By 48 hours of life—

Secondary

MeasureTime frame
To determine if LUS is superior to clinical criteria in guiding surfactant therapy as measured in terms of the following neonatal outcomes- Requirement of Mechanical ventilation Duration of mechanical ventilation Total duration of oxygen support Duration of NICU stay BPD free survival Timepoint: At 36 weeks of corrected gestational age / death—

Countries

India

Contacts

Public ContactDr Rajesh R N

All India Institute of Medical Sciences, Nagpur

sanjana.hs@aiimsnagpur.edu.in8940011358

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026