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Comparing two surfactant administration techniques to know which technique has better outcome result.

Comparative study between intubate surfactant administration and extubate (INSURE) vs lesser invasive surfactant administration(LISA) technique for delivery of surfactant in newborn with respiratory distress syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/033944
Enrollment
70
Registered
2021-06-02
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: J981- Pulmonary collapse

Interventions

Intervention1: Insure technique: Delivery of surfactant by INSURE technique in newborn with respiratory distress syndrome in newborn Control Intervention1: LISA: Delivery of surfactant by LISA techniq

Sponsors

Pushpender Singh Mehra
Lead Sponsor
Swami Dayanand hospital
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1)Preterm 28-36 weeks 2)Requirement of nasal continues airway pressure(ncpap) level beyond or equal to 5cm of water and fiO2 greater or equal to o. 30 to maintain sPO2 of 88-92%. 3)Requirement of nasal high flow nasal canula(NHHHFNC) level beyond or equal to 5L/min cm of water and fiO2 greater or equal to 0.3 to maintain sPO2 of 88-92%. 4)Requirement of free flow O2 to 2L/min cm of water and fiO2 greater or equal to 0.3 to maintain sPO2 of 88-92%.

Exclusion criteria

Exclusion criteria: 1)Severe respiratory distress syndrome with high oxygen requirement and or severe respiratory acidocissuch that ventilatory support will be necessary after surfactant therapy, suggested FiO2 threshold at which intubation for surfactant will be considered is >60(lower threshold) 2)Pulmonary hypoplasia 3)Cyanotic heart disease 4)Antinatally diagnosed congenital lung anomalies 5)Requirement intubation for resuscitation at birth

Design outcomes

Primary

MeasureTime frame
Need for mechanical ventilation in first 72 hours in preterm newborns with RDS administered surfactant by LISA and INSURE.Timepoint: Birth till first 72 hours—

Secondary

MeasureTime frame
Duration of mechanical ventilation needed between LISA and INSURE group Duration of hospital stay between the LISA AND INSURE group Need for supplement O2 between LISA and INSURE group.Timepoint: Birth till first 12 hours—

Countries

India

Contacts

Public ContactPushpender Singh Mehra

Swami Dayanand hospital department of pediatrics

anilsaini.0410@gmail.com9810075126

Outcome results

None listed

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