Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow

NCT06398691 | Completed DMC

• 1 other identifier: HU-MB-1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP.

Conditions

Respiratory Disease; Newborn Rds

Keywords

NEWBORN; Respiratory Distress Syndrome; Less Invasive Surfactant Administration; Heated Humidified High-Flow Air Support with Nasal Cannula.; Nasal Continuous Airway Pressure

Outcome Measures

Primary Outcomes (1)

• Investigation of the effect of surfactant treatment on the p02 value in blood gases using the LISA method in premature babies with spontaneous breathing during different respiratory support.

  A total of 34 premature babies were included in the study. There were 22 patients in the CPAP group and 12 patients in the HHHFNC group. It was planned to make a comparison between CPAP and HHHNFC groups in terms of bloog gas parameters before, during and after surfactant treatment. Blood gas analysis was performed immediately before and 120th, 360th minutes after surfactant administration. p02 values in blood gas were determined according to the routine protocol of our NICU. They were performed three times: immediately before the surfactant treatment and at the 120th and 360th minute after the surfactant was administered.

  360 minutes after surfactant treatment

Secondary Outcomes (1)

• Investigation of the effect of using surfactant treatment with the LISA method during different respiratory support on the pulse oximetry parameters of babies.

  360 minutes after surfactant treatment

Study Arms (2)

CPAP group

ACTIVE COMPARATOR

A Babylog 8000 neonatal ventilator (Dräger, Lübeck, Germany) for nasal CPAP support was used support . The nasal CPAP support had been applied through short binasal prongs (Optiflow Junior 2 nasal cannula) used as an interface. PEEP pressure was set to 6-8 cmH2O for nasal CPAP. The FiO2 was regulated to keep the oxygen-saturation value between 92% and 95%.

Device: Nazal CPAP

HHHFNC group

ACTIVE COMPARATOR

A Vapotherm® device (Vapotherm Inc., Stevensville, MD) for HHHFNC support was used. The airflow rate was set to 6-8 L/min for HHHFNC (heat: 37 °C). The HHHFNC support had been applied through the small bore cannula in the Vapotherm as an interface. The FiO2 was regulated to keep the oxygen-saturation value between 92% and 95%.

Device: Heated humidified high-flow air support with nasal cannula

Interventions

Nazal CPAP DEVICE

CPAP group

Heated humidified high-flow air support with nasal cannula DEVICE

HHHFNC group

Eligibility Criteria

• Age: 1 Minute - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Does not require intubation,
• Diagnosed with RDS
• Premature newborns receiving surfactant therapy in the first 72 hours of life
• Those whose families give written consent

You may not qualify if:

• Babies whose families do not give written consent
• Newborns diagnosed with early neonatal sepsis
• Newborns with inotropic requirements
• Neonates with hemodynamically significant PDA
• Babies of diabetic mothers
• Babies with a major congenital anomaly
• Newborns with hemodynamic instability,
• Those requiring endotracheal intubation,
• NEC (Stage 2 or higher),
• Those showing ICH (Stage 2 or higher)
• Babies with perfusion disorders in the first three days

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Melek Büyükeren

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

Related Publications (3)

• Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788.

  PMID: 18272893 RESULT

• Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.

  PMID: 27649091 RESULT

• Chao KY, Chen YL, Tsai LY, Chien YH, Mu SC. The Role of Heated Humidified High-flow Nasal Cannula as Noninvasive Respiratory Support in Neonates. Pediatr Neonatol. 2017 Aug;58(4):295-302. doi: 10.1016/j.pedneo.2016.08.007. Epub 2017 Jan 17.

  PMID: 28223010 RESULT

MeSH Terms

Conditions

Respiration Disorders; Pulmonary Atelectasis; Respiratory Distress Syndrome

Interventions

Cannula

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• MELEK BUYUKEREN

  Hacettepe University, Neonatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Premature newborns (gestational age \<370/7 weeks) who did not require intubation, who were diagnosed with RDS, and who were treated with surfactant in the first 72 hours of life were included in the study. Written informed consent was obtained from all of the infants' families before the infants were enrolled in the study. Noninvasive respiratory support was provided by nasal CPAP or HHHNFC, respectively, according to the time of admission to the intensive-care unit, so the patients were divided into two groups. During the study period, the noninvasive respiratory support method (nasal CPAP or HHHNFC) that the babies received did not change. Post-hoc, one-way difference between two independent means (two groups) statistical analysis was used. Significance P \< 0.05; effect size 0.9; power (1-ß err prob) was found to be 82%.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: May 3, 2024
• Study Start: January 10, 2017
• Primary Completion: November 23, 2017
• Study Completion: December 30, 2017
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

Locations

TU (1)