Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial

NCT06557551 | Recruiting

• 1 other identifier: proTeCt 01
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of life. The main question it aims to answer is: Do fewer babies who receive prophylactic thin catheter surfactant under video laryngoscopy shortly after birth go on to be ventilated within 72 hours of birth? Extremely premature babies who are receiving breathing support through a face mask will either:

• Receive surfactant through a thin catheter that is inserted into their windpipe (trachea) under video laryngoscopy at or after 5 minutes of life, have the catheter removed immediately, and return to face mask breathing support; or
• Continue on face mask breathing support. All babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.

Conditions

Infant, Newborn, Diseases; Prematurity; Prematurity; Extreme; Respiratory Distress Syndrome in Premature Infant

Outcome Measures

Primary Outcomes (1)

• Number of participants intubated in the first 72 hours of life

  Endotracheal intubation 1. in the Delivery Room for apnoea or bradycardia despite mask PPV; or 2. in the Neonatal Intensive Care Unit, for 2 or more of * worsening clinical signs respiratory distress * oxygen requirement \> 30% for \>30 mins to keep oxygen saturation (SpO2) \>90% * pH \< 7.2 on 2 blood gases 30 minutes apart * PCO2 \>9kPa on 2 blood gases 30 minutes apart * recurrent mask PPV for apnoea Participants reach the primary outcome if they are intubated with an endotracheal tube (ETT) for mechanical ventilation, with an ETT for surfactant and mechanical ventilation, with an ETT for surfactant alone, or with a thin catheter for surfactant alone

  First 72 hours of life

Secondary Outcomes (26)

• Number of participants in whom the thin catheter is seen on video laryngoscopy to be successfully inserted at first attempt (intervention group only)

  30 minutes

• Number of participants with bradycardia [heart rate (HR) < 100bpm] in the Delivery Room (DR)

  30 minutes

• Number of participants who receive mask Positive Pressure Ventilation (PPV) in the DR

  30 minutes

• Number of participants who undergo endotracheal intubation in the DR

  30 minutes

• Number of participants who receive chest compressions in the DR

  30 minutes

Study Arms (2)

Thin catheter surfactant

EXPERIMENTAL

At or after 5 minutes of life, participants will have a thin endotracheal catheter (Surfcath, Vygon, Ecouen, France) inserted under video laryngoscopy (C-MAC, Karl Storz, Tuttlingen, Germany), through which they will receive surfactant (Curosurf, Chiesi Farmaceutici, Parma, Italy - 120mg for infants \< 26 weeks, 240mg for infants 26 - 27+6 weeks). The catheter will then be removed, and they will continue on face mask breathing support.

Other: Thin catheter surfactant

Standard care

NO INTERVENTION

Participants will continue on face mask breathing support.

Interventions

Thin catheter surfactant OTHER

Surfactant given through thin catheter inserted under video laryngoscopy at or after 5 minutes of life

Thin catheter surfactant

Eligibility Criteria

• Age: Up to 30 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants of any sex born before 28 weeks of gestation
• Clinicians plan to provide intensive care
• Consent for their participation provided by parent(s)/guardian(s) before their birth

You may not qualify if:

• Major congenital anomalies (e.g. upper airway anomaly, diaphragmatic hernia, gastroschisis, exomphalos major, intestinal atresias, open neural tube defect, aneuploidy, cardiac lesions other than ASD/PFO/VSD/PDA )

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

National Maternity Hospital

Dublin, None Selected, D02 YH21, Ireland

RECRUITING

Related Publications (3)

• Abdel-Latif ME, Davis PG, Wheeler KI, De Paoli AG, Dargaville PA. Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2021 May 10;5(5):CD011672. doi: 10.1002/14651858.CD011672.pub2.

  PMID: 33970483 BACKGROUND

• Geraghty LE, Dunne EA, Ni Chathasaigh CM, Vellinga A, Adams NC, O'Currain EM, McCarthy LK, O'Donnell CPF. Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. N Engl J Med. 2024 May 30;390(20):1885-1894. doi: 10.1056/NEJMoa2402785. Epub 2024 May 5.

  PMID: 38709215 BACKGROUND

• Bahadue FL, Soll R. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD001456. doi: 10.1002/14651858.CD001456.pub2.

  PMID: 23152207 BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, Diseases; Premature Birth

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Colm PF O'Donnell

  National Maternity Hospital, University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colm PF O'Donnell, MB PhD

CONTACT

35316373100; codonnell@nmh.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, open-label, parallel group group study

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 16, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available 1 year after publication for 2 years
• Access Criteria: Participant data may be made available to other researchers on receipt of acceptable written request by principal Investigator

Locations

IE (1)