Surfactant Administration by Insure or Thin Catheter

Analgesia Clinical Trial

— SAINT  

Official title:

Surfactant Administration by Insure or Thin Catheter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04445571
• Other study ID #: 180367
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: Kajsa Bohlin, MD
• Phone: +46858580000
• Email: kajsa.bohlin[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To compare two approaches for surfactant administration during CPAP in preterm infants, the INSURE and the LISA technique, using premedication intubation protocols, and investigate aspects of safety, stress and pain, timely administration of the drug, response in oxygenation and pulmonary outcome.

Our study asks whether (P) among infants born <32 weeks' gestation with RDS (I) does surfactant administration with LISA and analgesia premedication (C) versus surfactant administration according to the INSURE protocol (O) improve oxygenation and reduce the rate of respiratory failure and need for intubation and mechanical ventilation (T) within 48 hours of the procedure

Primary outcomes:

1. Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24 hours post-procedure.

2. Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure.

Safety outcomes:

1. Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration

2. Number of tries before successful intubation/placement of catheter

3. Positive pressure ventilation during the procedure - yes/no/duration (minutes)

4. Stress and pain (changes in heart rate, blood pressure and BIIP-scale)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Analgesia
• RDS of Prematurity
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Surfactant Deficiency Syndrome Neonatal

Intervention

Procedure:
• Thin 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

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delay time	Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration	24 hours
Other	Intubation attempts	Number of tries before successful intubation/placement of catheter	24 hours
Other	PPV	Positive pressure ventilation during the procedure - yes/no/duration (minutes)	24 hours
Other	Stress and pain	Changes in heart rate, blood pressure and BIIP-scales	24 hours
Primary	Oxygenation	Arterial to alveolar ratio (a/A ratio)	24 hours post-procedure
Primary	Mechanical ventilation	Need for intubation and mechanical ventilation (MV)	48 hours post-procedure
Secondary	Duration of ventilatory support	Duration of MV (hours), CPAP (days), Oxygen (days)	Discharge
Secondary	Complications	Incidence of air leaks, bronchopulmonary dysplasia, Systemic hypotension, retinopathy, necrotizing entercolitis, intraventricular hemorrhage, persistent duct	Discharge
Secondary	Mortality	Death or composite outcome death/BPD	Discharge
Secondary	Length of stay	Number of days in NICU and total in neonatal care, including home care	Discharge