Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants

NCT06421506 | Not Yet Recruiting

• 1 other identifier: 324607
• Study Type: interventional
• Target: 245
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early. Less invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in. High flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose. The investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatment, compared to when they don't receive this treatment. The investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA.

Conditions

Respiratory Distress Syndrome; Preterm Pregnancy; Surfactant Deficiency Syndrome Neonatal

Outcome Measures

Primary Outcomes (1)

• The percentage of neonates needing invasive ventilation within 72 hours from birth

  The percentage of babies requiring more respiratory support and therefore needing invasive ventilation within 72 hrs from birth. The percentage from the intervention group will be compared with the control group

  72 hours from birth

Secondary Outcomes (8)

• The length of neonatal unit stay

  The length of time the neonate is in hospital, up to 20 weeks

• The cost of stay as estimated via standard NHS tariffs according to level of care

  The length of time the neonate is in hospital, up to 20 weeks

• The lung function parameters two minutes before and two minutes after the administration of LISA

  The first 24 hours of life

• The lung function parameters two minutes before and two minutes after the administration of LISA

  The first 24 hours of life

• The lung function parameters two minutes before and two minutes after the administration of LISA

  The first 24 hours of life

Study Arms (2)

Neonates given LISA during HFNC treatment

EXPERIMENTAL

Infants between 34-38+6 weeks gestation will receive surfactant via less invasive administration whilst on high flow nasal cannula oxygen treatment. They will have respiratory function monitoring before and after LISA.

Procedure: Less invasive surfactant administration during high flow nasal cannula treatment

Neonates not given LISA

NO INTERVENTION

Infants between 34-38+6 will receive routine care and will not receive surfactant unless intubated.

Interventions

Less invasive surfactant administration during high flow nasal cannula treatment PROCEDURE

Surfactant distilled through a small tube inserted into the windpipe via the mouth whilst the baby is awake and supported with HFNC.

Neonates given LISA during HFNC treatment

Eligibility Criteria

• Age: 34 Weeks - 38 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birth, but who achieve regular spontaneous breathing and have a heart rate over 100 beats per minute while receiving non-invasive support.
• Infants enrolled in the Surfon trial, born at 34+0 to 38+6 weeks of gestation, who are less than or equal to 24 hours old and exhibit signs of respiratory distress, defined as an FiO2 greater or equal to 0.30 but less than 0.45 needed to maintain an SpO2 greater than or equal to 92% or a clinically significant work of breathing regardless of the FiO2 and a clinical decision to provide non-invasive respiratory support.

You may not qualify if:

• Infants requiring intubation at birth
• Infants with severe congenital anomalies.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Chiesi Limited: collaborator

Related Publications (5)

• Herting E, Hartel C, Gopel W. Less invasive surfactant administration (LISA): chances and limitations. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F655-F659. doi: 10.1136/archdischild-2018-316557. Epub 2019 Jul 11.

  PMID: 31296694 BACKGROUND

• Shetty S, Egan H, Cornuaud P, Kulkarni A, Duffy D, Greenough A. Less Invasive Surfactant Administration in Very Prematurely Born Infants. AJP Rep. 2021 Jul;11(3):e119-e122. doi: 10.1055/s-0041-1735632. Epub 2021 Sep 22.

  PMID: 34567837 BACKGROUND

• Smithhart W, Wyckoff MH, Kapadia V, Jaleel M, Kakkilaya V, Brown LS, Nelson DB, Brion LP. Delivery Room Continuous Positive Airway Pressure and Pneumothorax. Pediatrics. 2019 Sep;144(3):e20190756. doi: 10.1542/peds.2019-0756. Epub 2019 Aug 9.

  PMID: 31399490 BACKGROUND

• Spence KL, Murphy D, Kilian C, McGonigle R, Kilani RA. High-flow nasal cannula as a device to provide continuous positive airway pressure in infants. J Perinatol. 2007 Dec;27(12):772-5. doi: 10.1038/sj.jp.7211828. Epub 2007 Aug 30.

  PMID: 17762844 BACKGROUND

• Jeffreys E, Jenkinson A, Kaltsogianni O, Harris C, Bhat R, Dassios T, Greenough A. Does less invasive surfactant administration during high-flow nasal cannula oxygen treatment reduce the need for invasive ventilation in late preterm and early term born infants with respiratory distress? A study protocol for a single-centre study with a treatment and control arm. BMJ Open. 2025 Jun 23;15(6):e089399. doi: 10.1136/bmjopen-2024-089399.

  PMID: 40550714 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Theodore Dassios, PHD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleanor Jeffreys, MBBS

CONTACT

+447519 974813; eleanor.jeffreys@nhs.net

Study Design

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

Model Details: This will be a prospective single centre study with a treatment arm and a control group.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 20, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share