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A study to evaluate the benefits of an alternative method of breathing support to premature babies with breathing difficulty.

Less invasive surfactant administration (LISA) in preterm neonates at 32 weeks & below with respiratory distress syndrome â?? A prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/06/053497
Enrollment
50
Registered
2023-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

None listed

Sponsors

Vishal Vishnu Tewari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All preterm neonates at and below 32 weeks period of gestation with moderate to severe RDS serially admitted to the NICU of Command hospital (WC), Chandimandir will be included in the study.

Exclusion criteria

Exclusion criteria: Neonates with major congenital anomalies, congenital heart diseases, gestation at and below 24 weeks or greater than 32 weeks, preterm neonates at and below 32 weeks with mild RDS not requiring intratracheal surfactant and neonates intubated at delivery for resuscitation.

Design outcomes

Primary

MeasureTime frame
To determine short-term respiratory outcomes in preterm neonates at 32 weeks & below with respiratory distress syndrome (RDS) given intratracheal surfactant by less invasive surfactant administration (LISA) technique measured as duration of respiratory support in hours.Timepoint: To determine short-term respiratory outcomes in preterm neonates at 32 weeks & below with respiratory distress syndrome (RDS) given intratracheal surfactant by less invasive surfactant administration (LISA) technique measured as duration of respiratory support in hours.

Secondary

MeasureTime frame
1. To determine the required number of doses of surfactant per patient 2. To determine the failure of LISA technique 3. To determine the procedure success rate 4. Incidence of mortality, bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), patent ductus arteriosus (PDA), necrotizing enterocolitis (NEC) & retinopathy of prematurity (ROP)Timepoint: By day of discharge from the hospital

Countries

India

Contacts

Public ContactVishal Vishnu Tewari

Command Hospital (WC) Chandimandir

docvvt_13@hotmail.com08826118889

Outcome results

None listed

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