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| Name | Class |
|---|---|
| Chiesi USA, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Length of hospital stay (LOS), days. | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Parent Bonding | Time to parent bonding from initial parent skin-to-skin contact. | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Duration of Mechanical Ventilation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anup Katheria, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Chula Vista Medical Center | Chula Vista | California | 91911 | United States | ||
| Sharp Grossmont Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33058208 | Background | 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. | |
| 24379227 | Background | 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. |
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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.
Beginning 6 months and ending 36 months following article publication.
Data and publication are available at http://clinicaltrials.gov
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|
| Continuous Positive Airway Pressure (CPAP) | Procedure | Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP). |
|
Total duration of mechanical ventilation (MV) with endotracheal tube, days.
| From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Duration of Continuous Positive Airway Pressure | Total duration of Continuous Positive Airway Pressure (CPAP), days. | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Duration of Non-Invasive Respiratory Support | Duration of non-invasive respiratory support with positive pressure and/or high flow, days. | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Oxygen Administration | Oxygen administration requirements for Fraction of Inspired Oxygen (FiO2). | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| RSS Score at 24 hours of age | Respiratory Severity Score (RSS) | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Surfactant Administration | Surfactant administration (additional dose administered to infants randomized to receive surfactant or any surfactant to infants receiving expectant CPAP management). | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Time to Initial Feed | Time to initial breastfeeding (including dry or nutritive) or oral feeding. | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Time to Full Feeds | Time to full feeds i.e. no parenteral nutrition. | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Incidence of Pneumothorax | Incidence of pneumothorax/ pulmonary air leaks. | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Incidence of Respiratory Failure | Defined as any of the following: Respiratory Severity Score (RSS) >2.1, Silverman Andersen (SAS) ≥6, Respiratory acidosis, severe apnea | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Incidence of Late Onset Sepsis | Incidence of late onset sepsis. | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Maternal Length of Stay | Maternal total length of stay. | From hospital admission to study completion at hospital discharge after birth. |
| Feeds at discharge | Breastfeeding at time of discharge (yes/no). | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| Parent-Infant Separation | Time to parental skin-to-skin contact | From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. |
| La Mesa |
| California |
| 91942 |
| United States |
| Sharp Mary Birch Hospital for Women & Newborns | San Diego | California | 92123 | United States |
| 34902013 | Background | 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. |
| 37538537 | Background | 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. |
| 34686533 | Background | 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. |
| 30518796 | Background | 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. |
| 37393396 | Background | 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. |
| 38320499 | Background | 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. |
| 32080333 | Background | 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. |
| 38583712 | Background | 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. |
| 27725928 | Background | 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. |
| 20664042 | Background | 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. |
| 21775849 | Background | 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. |
| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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