Enrolling by invitation NCT07176117
Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA), Continuous Positive Airway Pressure (CPAP).
- Who it may be relevant to
- Registry conditions: Respiratory Distress Syndrome (Neonatal), Surfactant. Basic parameters: 33 Weeks — 38 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Surfactant Prophylaxis in LAte Preterm to Early Term Infants Using a Supraglottic Airway Device to Help Improve Outcomes
Overview
The purpose of this research is to learn new information that may help other infants that have respiratory distress syndrome and need breathing support after birth. The goal of this research is to see if continuous positive airway pressure (CPAP) alone or CPAP with surfactant administration through a less invasive method via an Airway Device (supraglottic airway device) temporarily placed above the vocal cords is better for treating respiratory distress syndrome in late preterm and early term infants.
Interventions
- Procedure Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)
A single dose of surfactant will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). A supraglottic airway device will be used as a standardized procedure for surfactant administration via SALSA using an AirLife Air-Q. - Procedure Continuous Positive Airway Pressure (CPAP)
Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).
Primary outcome measures
- Difference in Ranked Composite of Morbidities [Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.]
Secondary outcome measures (1)
- Length of Hospital Stay [Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.]
Eligibility criteria
Inclusion criteria
- Newborns 33-38+6 weeks gestation at birth
- ≤ 6 hours old
- Respiratory Distress: \[Silverman Andersen Score (SAS) ≥ 5, or Respiratory Severity Score (RSS) ≥ 1.25\]
- Clinical decision for non-invasive respiratory support
- Written parental consent
Exclusion criteria
- Surrogate deliveries
- Major congenital or chromosomal anomalies
- Prior intubation or receipt of surfactant
- Known or suspected hypoxic ischemic encephalopathy (HIE)
- Known or suspected neuromuscular disorder
- Unanticipated survival
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Sharp Chula Vista Medical Center — Chula Vista
- Sharp Grossmont Hospital — La Mesa
- Sharp Mary Birch Hospital for Women & Newborns — San Diego
Publications
- Ho JJ, Subramaniam P, Davis PG. Continuous positive airway pressure (CPAP) for respiratory distress in preterm infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD002271. doi: 10.1002/14651858.CD002271.pub3. PMID 33058208
- Polin RA, Carlo WA; Committee on Fetus and Newborn; American Academy of Pediatrics. Surfactant replacement therapy for preterm and term neonates with respiratory distress. Pediatrics. 2014 Jan;133(1):156-63. doi: 10.1542/peds.2013-3443. Epub 2013 Dec 30. PMID 24379227
- Dargaville PA, Kamlin COF, Orsini F, Wang X, De Paoli AG, Kanmaz Kutman HG, Cetinkaya M, Kornhauser-Cerar L, Derrick M, Ozkan H, Hulzebos CV, Schmolzer GM, Aiyappan A, Lemyre B, Kuo S, Rajadurai VS, O'Shea J, Biniwale M, Ramanathan R, Kushnir A, Bader D, Thomas MR, Chakraborty M, Buksh MJ, Bhatia R, Sullivan CL, Shinwell ES, Dyson A, Barker DP, Kugelman A, Donovan TJ, Tauscher MK, Murthy V, Ali SK PMID 34902013
- Ramaswamy VV, Bandyopadhyay T, Abiramalatha T, Pullattayil S AK, Szczapa T, Wright CJ, Roehr CC. Clinical decision thresholds for surfactant administration in preterm infants: a systematic review and network meta-analysis. EClinicalMedicine. 2023 Jul 20;62:102097. doi: 10.1016/j.eclinm.2023.102097. eCollection 2023 Aug. PMID 37538537
- Ramaswamy VV, Abiramalatha T, Bandyopadhyay T, Boyle E, Roehr CC. Surfactant therapy in late preterm and term neonates with respiratory distress syndrome: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2022 Jul;107(4):393-397. doi: 10.1136/archdischild-2021-322890. Epub 2021 Oct 22. PMID 34686533
- Calevo MG, Veronese N, Cavallin F, Paola C, Micaglio M, Trevisanuto D. Supraglottic airway devices for surfactant treatment: systematic review and meta-analysis. J Perinatol. 2019 Feb;39(2):173-183. doi: 10.1038/s41372-018-0281-x. Epub 2018 Dec 5. PMID 30518796
- Lockyear C, Coe K, Greenberg RG, Clark RH, Aleem S. Trends in morbidities of late preterm infants in the neonatal intensive care unit. J Perinatol. 2023 Nov;43(11):1379-1384. doi: 10.1038/s41372-023-01705-5. Epub 2023 Jul 1. PMID 37393396
- Katheria A, Ines F, Banerji A, Hopper A, Uy C, Chundu A, Coughlin K, Hutson S, Morales A, Sauberan J, Poeltler D, Dorner R, Rich W, Finer N. Caffeine and Less Invasive Surfactant Administration for Respiratory Distress Syndrome of the Newborn. NEJM Evid. 2023 Dec;2(12):EVIDoa2300183. doi: 10.1056/EVIDoa2300183. Epub 2023 Nov 21. PMID 38320499
Identifiers
NCT: NCT07176117 · SPLASH