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Surfactant are alveolar surface reducing agents,used in preterm baby having lower pool surfactant i.e. respiratory distress syndrome. Sedation and pain reducing drug administration during surfactant therapy by less invasive technique will be assessed in this trial.

Fentanyl versus placebo before less invasive surfactant administration: A Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041453
Enrollment
320
Registered
2022-03-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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: Fentanyl administration during Less Invasive Surfactant Administration: Patients having RDS who required FiO2 more than 30 % on Noninvasive positive pressure ventilation to maintain SpO

Sponsors

IPGMER SSKM HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm baby with gestational age between 28 to 34 weeks diagnosed with RDS will enroll in this study . RDS will be diagnosed clinically initially and later confirm by chest X ray . A written informed consent will be obtained from the parents of the baby for participation in the study

Exclusion criteria

Exclusion criteria: Baby with major congenital anomaly . Perinatal asphyxia (cord blood pH Intubated at delivery room. Alternative cause of respiratory distress.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the need for mechanical ventilation from the LISA procedure onwards up to 72 h of life.Timepoint: The primary outcome is the need for mechanical ventilation from the LISA procedure onwards up to 72 h of life.

Secondary

MeasureTime frame
Number of laryngoscopy attempts during the procedure Complications occurring during and after the procedure SpO2 80 percentage hypotension with mean below gestational age bradycardia 100 bpm Incidence of hsPDA IVH above grade3 Broncho Pulmonary Dysplasia Retinopathy of Prematurity requiring treatment Culture positive sepsis Necrotizing Enterocolitis above stage 3 Rate of feed intolerance Gastrointestinal perforation confirmed on roentgenogram or surgical exploration Timepoint: 3month

Countries

India

Contacts

Public ContactDr Bijan Saha

Institute of PostGraduate Medical Education and Research and SSKM Hospital

bijansaha18@gmail.com09051389120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026