RecruitingNot ApplicableNCT04445571

Surfactant Administration by Insure or Thin Catheter


Sponsor

Karolinska Institutet

Enrollment

160 participants

Start Date

May 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.


Eligibility

Max Age: 2 Days

Inclusion Criteria1

  • Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment.

Exclusion Criteria2

  • Infants requiring surfactant as part of delivery room resuscitation are not eligible.
  • Infants will be excluded from the final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia; tracheo-oesophageal fistula or cyanotic heart disease.

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Interventions

PROCEDUREThin catheter technique or standard ET-tube for surfactant administration

Surfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP.


Locations(1)

Karolinska University Hospital

Stockholm, Sweden

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NCT04445571


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