A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT02772081
• Date of registration: 06/05/2016
• Prospective Registration: Yes
• Primary sponsor: Chiesi Farmaceutici S.p.A.
• Public title: A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration LISPAP
• Scientific title: An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates With Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (Poractant Alfa, CUROSURF®) Administration: A Less Invasive Method (LISA) During Non-invasive Ventilation (NIV) and the Conventional Administration During Brief Invasive Ventilation.
• Date of first enrolment: May 18, 2021
• Target sample size: 33
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT02772081
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Italy, United States

Contacts

• Name: Rangasamy Ramanathan, M.D.
• Affiliation: LAC+USC Medical Center & Good Samaritan Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written informed consent obtained by parents/legal representative (according to local
regulation) prior to or after birth

2. Preterm neonates of either sex aged =30 minutes and <24 hours, spontaneously breathing
and stabilized on non-invasive ventilation (NIV).

3. Gestational age of 25+0 weeks up to 28+6 completed weeks, except for the first 15
enrolled neonates in which the gestational age will be restricted to 27+0 weeks up to
28+6 weeks.

4. Clinical course consistent with RDS.

5. Fraction of inspired oxygen (FiO2) =0.30 to maintain preductal oxygen saturation
(SpO2) between 88-95%.

Exclusion Criteria:

1. Need for immediate endotracheal intubation for cardiopulmonary resuscitation or
insufficient respiratory drive

2. Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry

3. Use of surfactant prior to study entry and need for intratracheal administration of
any other treatment (e.g. nitric oxide)

4. Known genetic or chromosomal disorders, major congenital anomalies (congenital heart
diseases, myelomeningocele etc)

5. Mothers with prolonged rupture of the membranes (> 21 days duration)

6. Presence of air leaks if identified and known prior to study entry

7. Evidence of severe birth asphyxia (e.g. continued need for resuscitation at 10 minutes
after birth, altered neurological state, or neonatal encephalopathy)

8. Neonatal seizures prior to study entry

9. Any condition that, in the opinion of the Investigator, would place the neonate at
undue risk

10. Participation in another clinical trial of any medicinal product, placebo,
experimental medical device, or biological substance conducted under the provisions of
a protocol on the same therapeutic target.



Age minimum: 30 Minutes
Age maximum: 24 Hours
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Distress Syndrome (RDS)

Intervention(s)

Drug: Curosurf through conventional administration (endotracheal tube)

Combination Product: LISA combination product (Curosurf+catheter CHF6440)

Primary Outcome(s)

Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion [Time Frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.]

Safety: Study Treatment Administration: Duration of Surfactant Administration [Time Frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.]

Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment [Time Frame: First 72 hours of life.]

Safety: Study Treatment Administration: Number of Device Misallocation for LISA Administration Group (Esophageal Insertion) [Time Frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.]

Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube [Time Frame: At first surfactant administration, up to Day 1.]

Safety: Study Treatment Administration: Duration of the Whole Procedure [Time Frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.]

Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization [Time Frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.]

Secondary Outcome(s)

Efficacy: Percentage of Neonates Needing Invasive Mechanical Ventilation (MV) During the Study [Time Frame: First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks PMA]

Efficacy: Duration of Invasive Mechanical Ventilation During the Study [Time Frame: First 72 hours of life]

Efficacy: Percentage of Neonates Needing Any Intubation Procedure, Outside the Initial Surfactant Administration Period [Time Frame: First 72 hours of life, up to 28 days post-natal age (PNA), Up to 36 weeks Post-menstrual age (PMA)]

Efficacy: Blood Analysis Parameter -- Base Excess [Time Frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)]

Efficacy: Blood Analysis Parameter -- Bicarbonate (HCO3^-) [Time Frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)]

Efficacy: Blood Analysis Parameter -- Lactate [Time Frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)]

Efficacy: Median Duration of Invasive Mechanical Ventilation During the Study [Time Frame: Up to 28 days PNA, Up to 36 weeks PMA]

Efficacy: Blood Gas Analysis Parameters -- Partial Pressure of Carbon Dioxide (pCO2) [Time Frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)]

Efficacy: Blood Gas Analysis Parameters -- Partial Pressure of Oxygen (pO2) [Time Frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)]

Efficacy: Preductal Oxygen Saturation (SpO2) [Time Frame: Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.]

Efficacy: Duration of Oxygen Alone Supplementation and Any Non-Invasive Ventilation (NIV) [Time Frame: First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks Post-Menstrual Age (PMA).]

Efficacy: Preductal Oxygen Saturation/Fraction of Inspired Oxygen (SpO2/FiO2) Ratio [Time Frame: Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.]

Efficacy: Fraction of Inspired Oxygen (FiO2) [Time Frame: Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.]

Efficacy: Neonates Needing Additional 2 or 3 Doses of Surfactant [Time Frame: First 72 hours of life.]

Efficacy: Neonates Needing Additional Surfactant Doses [Time Frame: First 72 hours of life.]

Efficacy: Blood Gas Analysis Parameters -- pH [Time Frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)]

Secondary ID(s)

CCD-050000-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/11/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02772081