Comparing two techniques of lung Fluid administration in babies with breathing difficulty who are born before 37 weeks of pregnancy

Administration of surfactant by modified InSurE Vs InSurE in preterm neonates with Respiratory Distress Syndrome â?? A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021690

Enrollment

152

Registered

2019-10-16

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: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: Modified INSURE technique: Preterm infants with RDS will receive surfactant by new technique in which Surfactant will be delivered without IPPV while baby will be connecte

Eligibility

Inclusion criteria

Inclusion criteria: Neonates more than or equal to 26 weeks of gestation with Respiratory distress syndrome within 24 hours of life and spontaneously breathing on Nasal Continuous positive airway pressure who require surfactant treatment

Exclusion criteria

Exclusion criteria: 1.Need for mechanical ventilation before enrollment 2.Major congenital malformation

Design outcomes

Primary

Measure	Time frame
To compare the incidence of mechanical ventilation within 72 hours of life between both groups (Modified InSurE versus InSurE group)Timepoint: 72 hours of life	—

Secondary

Measure	Time frame
1.incidence of procedure related complications a) Apnea b) Bradycardia c).Desaturation 2.Incidence of Surfactant reflux during procedure 3.need for mechanical ventilation 4.mortality 5.Incidence of BPD as per NICHD. 6.Duration of Hospital stay 7.Incidence of grade 3 or 4 IVH before discharge. 8.Total number of surfactant doses required Timepoint: 1. within 15 minutes 2. during procedure 3. within 72 hours 4. before discharge 5. before discharge 6. before discharge 7. before discharge 8. within 24 hours	—

Measure

Time frame

1.incidence of procedure related complications a) Apnea b) Bradycardia c).Desaturation 2.Incidence of Surfactant reflux during procedure 3.need for mechanical ventilation 4.mortality 5.Incidence of BPD as per NICHD. 6.Duration of Hospital stay 7.Incidence of grade 3 or 4 IVH before discharge. 8.Total number of surfactant doses required Timepoint: 1. within 15 minutes 2. during procedure 3. within 72 hours 4. before discharge 5. before discharge 6. before discharge 7. before discharge 8. within 24 hours

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Countries

India

Contacts

Public ContactDr Adhisivam B

JIPMER

adhisivam1975@yahoo.co.uk9488822113

Outcome results

None listed

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