Respiratory Distress Syndrome (Neonatal)SPLASHNCT07176117

Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants

A study testing Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA) and Continuous Positive Airway Pressure (CPAP) in people with Respiratory Distress Syndrome (Neonatal) and Surfactant, run by Sharp HealthCare at 3 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 33 to 38 weeks
Conditions the study is for: Respiratory Distress Syndrome (Neonatal), Surfactant
What is being tested?: Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA) and Continuous Positive Airway Pressure (CPAP)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 422 participants
Where: 3 sitesUnited States
Study dates: 20 Nov 2025to 30 Jun 2031
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 33 to 38 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites

Sharp Chula Vista Medical Center
Chula Vista, California, 91911
Sharp Grossmont Hospital
La Mesa, California, 91942
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123

Other trials in United States

About this study

Official title: Surfactant Prophylaxis in LAte Preterm to Early Term Infants Using a Supraglottic Airway Device to Help Improve Outcomes

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.

Conditions: Respiratory Distress Syndrome (Neonatal), Surfactant
Being tested: Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA), Continuous Positive Airway Pressure (CPAP)
Keywords: supraglottic airway device
Medical subject headings: Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)Procedure or surgery
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.
Continuous Positive Airway Pressure (CPAP)Procedure or surgery
Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).

Study groups in NCT07176117
Study group	Role	What they receive
Prophylactic Surfactant	Experimental	A single dose of surfactant (Curosurf) will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). Infants who receive SALSA will remain on non-invasive respiratory support (Continuous Positive Airway Pressure). Receives: Procedure: Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)
Expectant Management (CPAP)	Active comparator	For participating infants randomly assigned to receive continuation of non-invasive respiratory support, they will remain on continuous positive airway pressure (CPAP). Receives: Procedure: Continuous Positive Airway Pressure (CPAP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Ranked Composite of Morbidities
Determine if there is a difference in ranked composite of morbidities including death, development of pneumothorax/ pulmonary air leaks, Respiratory Severity Score (RSS), time to initial feeding, and LOS (length of hospital stay) between the treatment and control groups using a linked count of participants who fall within each prespecified rank.
Measured: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.

Secondary outcomes (1)

Length of Hospital Stay
Length of hospital stay (LOS), days.
Measured: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 202530 Jun 2031

First posted16 Sep 2025
Study start20 Nov 2025
Primary completion31 Dec 2030 (estimated)
Study completion30 Jun 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Respiratory Distress Syndrome (Neonatal)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 422 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07176117
Sponsor's protocol ID: SPLASH
Acronym: SPLASH
Status last verified: Jul 2026
First submitted: 27 Aug 2025
Last updated: 13 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data, particularly data that underlie the results reported in this article after deidentification will be available with other researchers, including data dictionaries for meta-analysis.

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.
PubMed 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.
PubMed 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 SKM, Yossuck P, Clark HW, Soll RF, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2478-2487. doi: 10.1001/jama.2021.21892.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 38320499
Jackson W, Taylor G, Bamat NA, Zimmerman K, Clark R, Benjamin DK, Laughon MM, Greenberg RG, Hornik CP. Outcomes associated with surfactant in more mature and larger premature infants with respiratory distress syndrome. J Perinatol. 2020 Aug;40(8):1171-1177. doi: 10.1038/s41372-020-0625-1. Epub 2020 Feb 20.
PubMed 32080333
Berger DS, Garg B, Penfield CA, Caughey AB. Respiratory distress syndrome is associated with increased morbidity and mortality in late preterm births. Am J Obstet Gynecol MFM. 2024 Jun;6(6):101374. doi: 10.1016/j.ajogmf.2024.101374. Epub 2024 Apr 5.
PubMed 38583712
Olivier F, Nadeau S, Caouette G, Piedboeuf B. Association between Apnea of Prematurity and Respiratory Distress Syndrome in Late Preterm Infants: An Observational Study. Front Pediatr. 2016 Sep 26;4:105. doi: 10.3389/fped.2016.00105. eCollection 2016.
PubMed 27725928
Consortium on Safe Labor; Hibbard JU, Wilkins I, Sun L, Gregory K, Haberman S, Hoffman M, Kominiarek MA, Reddy U, Bailit J, Branch DW, Burkman R, Gonzalez Quintero VH, Hatjis CG, Landy H, Ramirez M, VanVeldhuisen P, Troendle J, Zhang J. Respiratory morbidity in late preterm births. JAMA. 2010 Jul 28;304(4):419-25. doi: 10.1001/jama.2010.1015.
PubMed 20664042
Spong CY, Mercer BM, D'Alton M, Kilpatrick S, Blackwell S, Saade G. Timing of indicated late-preterm and early-term birth. Obstet Gynecol. 2011 Aug;118(2 Pt 1):323-333. doi: 10.1097/AOG.0b013e3182255999.
PubMed 21775849

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
Not yet recruitingObservational study
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Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
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All Respiratory Distress Syndrome (Neonatal) trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Surfactant Prophylaxis in LAte Preterm to Early Term Infants Using a Supraglottic Airway Device to Help Improve Outcomes
ClinicalTrials.gov ID: NCT07176117
Acronym / sponsor ID: SPLASH / SPLASH
Conditions: Respiratory Distress Syndrome (Neonatal), Surfactant
Keywords: supraglottic airway device
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 422 participants (estimated)
Lead sponsor: Sharp HealthCareUniversity, hospital or other
Collaborators: Chiesi USA, Inc.
Study start: 20 Nov 2025 (actual)
Primary completion: 31 Dec 2030 (estimated)
Study completion: 30 Jun 2031 (estimated)
First posted: 16 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Prophylactic Surfactant	Experimental	Procedure: Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)A single dose of surfactant (Curosurf) will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). Infants who receive SALSA will remain on non-invasive respiratory support (Continuous Positive Airway Pressure).
Expectant Management (CPAP)	Active comparator	Procedure: Continuous Positive Airway Pressure (CPAP)For participating infants randomly assigned to receive continuation of non-invasive respiratory support, they will remain on continuous positive airway pressure (CPAP).

Who may qualify

Ages: 33 to 38 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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 or surgery	Prophylactic Surfactant
Continuous Positive Airway Pressure (CPAP)Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).	Procedure or surgery	Expectant Management (CPAP)

Primary outcome

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.
Determine if there is a difference in ranked composite of morbidities including death, development of pneumothorax/ pulmonary air leaks, Respiratory Severity Score (RSS), time to initial feeding, and LOS (length of hospital stay) between the treatment and control groups using a linked count of participants who fall within each prespecified rank.

1 secondary outcome

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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Background: PubMed 33058208Ho 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.
Background: PubMed 24379227Polin 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.
Background: PubMed 34902013Dargaville 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 SKM, Yossuck P, Clark HW, Soll RF, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2478-2487. doi: 10.1001/jama.2021.21892.
Background: PubMed 37538537Ramaswamy 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.
Background: PubMed 34686533Ramaswamy 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.
Background: PubMed 30518796Calevo 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.
Background: PubMed 37393396Lockyear 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.
Background: PubMed 38320499Katheria 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.
Background: PubMed 32080333Jackson W, Taylor G, Bamat NA, Zimmerman K, Clark R, Benjamin DK, Laughon MM, Greenberg RG, Hornik CP. Outcomes associated with surfactant in more mature and larger premature infants with respiratory distress syndrome. J Perinatol. 2020 Aug;40(8):1171-1177. doi: 10.1038/s41372-020-0625-1. Epub 2020 Feb 20.
Background: PubMed 38583712Berger DS, Garg B, Penfield CA, Caughey AB. Respiratory distress syndrome is associated with increased morbidity and mortality in late preterm births. Am J Obstet Gynecol MFM. 2024 Jun;6(6):101374. doi: 10.1016/j.ajogmf.2024.101374. Epub 2024 Apr 5.
Background: PubMed 27725928Olivier F, Nadeau S, Caouette G, Piedboeuf B. Association between Apnea of Prematurity and Respiratory Distress Syndrome in Late Preterm Infants: An Observational Study. Front Pediatr. 2016 Sep 26;4:105. doi: 10.3389/fped.2016.00105. eCollection 2016.
Background: PubMed 20664042Consortium on Safe Labor; Hibbard JU, Wilkins I, Sun L, Gregory K, Haberman S, Hoffman M, Kominiarek MA, Reddy U, Bailit J, Branch DW, Burkman R, Gonzalez Quintero VH, Hatjis CG, Landy H, Ramirez M, VanVeldhuisen P, Troendle J, Zhang J. Respiratory morbidity in late preterm births. JAMA. 2010 Jul 28;304(4):419-25. doi: 10.1001/jama.2010.1015.
Individual participant dataSharing planned: Yes. Individual participant data, particularly data that underlie the results reported in this article after deidentification will be available with other researchers, including data dictionaries for meta-analysis.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Anup Katheria, MD principal investigator

Sharp HealthCare

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07176117, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.