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A clinical trial to study the effects of two methods of surfactant administration, through Laryngeal mask airway and endotracheal tube in preterm babies with Respiratory distress syndrome

Laryngeal mask airway Versus Endotracheal tube for Surfactant administration in Respiratory Distress Syndrome in Preterm neonates more than 30 weeks of gestation-A Randomized Control Trial

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/12/007540
Enrollment
176
Registered
2016-12-06
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: null- Respiratory distress syndrome

Interventions

Intervention1: Intervention group : Surfactant administration through Laryngeal mask airway : surfactant would be administered through the babies diagnosed ton have respiratory distress syndrome thro

Sponsors

Dr Ramkumaar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Birth weight of more than 1200 grams 2.Gestational age of more than 30 weeks 3.Chronological age of less than 48 hours 4.Diagnosis of RDS with clinical and radiological criteria 5.Requiring nasal CPAP with Peep of less than 7 and FiO2 between 0.4 to 0.7 6.Hemodynamically stable A written consent will be obtained from the parents / care givers of the infant for willingness for enrolment in the study

Exclusion criteria

Exclusion criteria: 1.Babies who underwent Endotracheal intubation earlier 2.Analgesia & or sedation during first 6 hours of life 3.APGAR score of less than 3 at 5 minutes of life 4.Babies with Major congenital anomalies

Design outcomes

Primary

MeasureTime frame
Need for mechanical ventilation within 48 hours of interventionTimepoint: 48 hours

Secondary

MeasureTime frame
1.Any need for mechanical ventilation 2.Evaluation of pain (Neonatal Infant Pain score) 3.Duration of oxygen requirement 4.Rate of pneumothorax 5.Compilations related to the intervention 6.Incidence of Sepsis 7.MortalityTimepoint: Till the time of discharge

Countries

India

Contacts

Public ContactDr Ramkumaar

Affiliation

drmangalabharathi@gmail.com9840786836

Outcome results

None listed

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