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Pain reducing drug administration during surfactant therapy by less invasive technique . Surfactant are alveolar surface reducing agents,used in baby having lower pool surfactant i.e. respiratory distress syndrome.

Analgesia during less invasive surfactant administration (LISA) : a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027144
Enrollment
34
Registered
2020-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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 maint

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 end point will be the percentage of infants with a Revised Premature Infant Pain Profile score less than 10 during the LISA procedureTimepoint: 10 minute within the procedure—

Secondary

MeasureTime frame
The occurrence of positive PPV within 48hr after the procedure. Intubation need during the procedure and within 24 hours . Number of attempts of insertion of the orogastric tube duration of the procedure . Complications occurring during the procedure . Duration of respiratory support . Duration of hospital stay . Timepoint: 6 month—

Countries

India

Contacts

Public ContactMd Habibullah Sk

IPGMER SSKM HOSPITAL

bijansaha18@gmail.com9051389120

Outcome results

None listed

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