Respiratory Distress Syndrome Clinical Trial
Official title:
Does Less Invasive Surfactant Administration (LISA) During High-flow Nasal Cannula Oxygen Treatment Reduces the Need for Invasive Ventilation in Late Preterm and Term Born Infants With Respiratory Distress?
NCT number | NCT06421506 |
Other study ID # | 324607 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | September 2026 |
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.
Status | Not yet recruiting |
Enrollment | 245 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 34 Weeks to 38 Weeks |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Infants requiring intubation at birth - Infants with severe congenital anomalies. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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King's College Hospital NHS Trust | Chiesi Limited |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The length of neonatal unit stay | The duration of stay on the neonatal unit will be compared between the babies receiving the intervention, and those who are not. | The length of time the neonate is in hospital, up to 20 weeks | |
Secondary | The cost of stay as estimated via standard NHS tariffs according to level of care | Standard NHS tariffs will be used to calculate the total cost of the stay for the babies in the intervention vs control group. | The length of time the neonate is in hospital, up to 20 weeks | |
Secondary | The lung function parameters two minutes before and two minutes after the administration of LISA | The following lung function parameter: tidal volume will be measured for all babies receiving LISA. | The first 24 hours of life | |
Secondary | The lung function parameters two minutes before and two minutes after the administration of LISA | The following lung function parameter: respiratory rate will be measured for all babies receiving LISA. | The first 24 hours of life | |
Secondary | The lung function parameters two minutes before and two minutes after the administration of LISA | The following lung function parameter: fraction of inspired oxygen (FiO2) will be measured for all babies receiving LISA. | The first 24 hours of life | |
Secondary | The lung function parameters two minutes before and two minutes after the administration of LISA | The following lung function parameter: End Tidal CO2 (ETCO2) will be measured for all babies receiving LISA. | The first 24 hours of life | |
Secondary | The lung function parameters two minutes before and two minutes after the administration of LISA | The following lung function parameter: ratio of oxygen saturations/ fractions of inspired oxygen (SpO2/ FiO2 ratio) will be measured for all babies receiving LISA. | The first 24 hours of life | |
Secondary | The SpO2/FiO2 ratio will be measured two hours after LISA administration | Lung function parameter: ratio SpO2/FiO2 will be measured two hours after LISA administration for all babies receiving LISA | The first 24 hours of life |
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