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

Phase 2/3

Recruiting

Conditions: Respiratory distress syndrome

Registration Number: CTRI/2016/12/007540

Lead Sponsor: Dr Ramkumaar

Brief Summary: This study is a randomized, open labelled, parallel group, single-centred trail comparing the safety and efficacy of surfactant administration through laryngeal mask airway and endotracheal tube in preterm neonates more than 30 weeks of gestation. This study was designed based on the hypothesis that Surfactant administration through Laryngeal mask airway will decrease the need for intubation in babies with Respiratory distress syndrome , when compared to standard surfactant administration through endotracheal tube in preterm neonates more than 30 weeks of gestation.

Primary outcomes measured would be the need for mechanical ventilation within 48 hours of intervention. The secondary outcomes measured would be any need for mechanical ventilation, evaluation of pain scores (Neonatal Infant Pain score), duration of oxygen requirement, rate of pneumothorax, compilations related to the interventions, incidence of Sepsis and mortality rate.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 176

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Need for mechanical ventilation within 48 hours of intervention	48 hours

Secondary Outcome Measures

Name	Time	Method
1.Any need for mechanical ventilation	2.Evaluation of pain (Neonatal Infant Pain score)

Trial Locations

Locations (1): Number 99, 1ST floor, Department of Neonatology,Institute of child health and hospital for children
🇮🇳
Chennai, TAMIL NADU, India
Number 99, 1ST floor, Department of Neonatology,Institute of child health and hospital for children
🇮🇳Chennai, TAMIL NADU, India
Dr Ramkumaar
Principal investigator
9790971177
rampaediatricsmddm@gmail.com