Heated, Humidified High-flow Nasal (HHHFN) Cannula vs Nasal Continuous Positive Airway Pressure in Respiratory Distress in Premature Neonates

NCT07891494 | Completed Phase 4 DMC

• 1 other identifier: 240827
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Newborn babies who have difficulty breathing may need breathing support to help them receive enough oxygen. Two commonly used methods are heated, humidified high-flow nasal cannula (HHFNC), which delivers warmed, moist air and oxygen through small tubes in the nose, and nasal continuous positive airway pressure (nCPAP), which helps keep the lungs open by delivering air and oxygen under gentle pressure through a nasal mask or tubes. This study will compare these two methods in newborn babies born at 28 weeks of pregnancy or later who develop breathing difficulties within the first 24 hours after birth. The study will be conducted in the neonatal intensive care unit at PAF Hospital Islamabad and will include 100 newborn babies. Participants will be randomly assigned to receive either HHFNC or nCPAP as their initial breathing support. The main purpose is to compare how often each method fails to provide adequate breathing support within the first 72 hours, requiring a change to another form of breathing support or insertion of a breathing tube for mechanical ventilation. The study will also assess other outcomes, including nasal injury, survival until hospital discharge, need for surfactant treatment, duration of breathing support and oxygen therapy, time to achieve full feeding, intestinal complications, and length of hospital stay. The findings may help improve understanding of the effectiveness and safety of these two breathing support methods in newborn babies with breathing difficulties.

Conditions

Neonatal Respiratory Distress Syndrome

Keywords

neonatal respiratory distress syndrome; nCPAP; HFNC; Broncho-pulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• Treatment Failure

  Efficacy will be assessed on basis of treatment failure. Treatment failure defined as requiring intubation or other non-invasive respiratory support within 72 h of starting intervention. Mechanical ventilation will be considered when 1. Sustained increase in oxygen requirement: FiO2\>0.40 to maintain SpO2 of 90%-94% for more than 2 hour 2. Respiratory acidosis: potential of Hydrogen (pH)≤7.20 and PaCO2\>60 mm Hg 3. Frequent or severe apnea despite drug therapy or respiratory support: two or more apnea events requiring bag-mask ventilation within 24 h

  72 hours of starting treatment

Study Arms (2)

Heated Humidified High-Flow Nasal Cannula therapy Group

ACTIVE COMPARATOR

Combination Product: Heated Humidified High-Flow Nasal Cannula therapy

N-CPAP Group

ACTIVE COMPARATOR

Combination Product: nCPAP

Interventions

Heated Humidified High-Flow Nasal Cannula therapy COMBINATION_PRODUCT

HFNC will be provided by devices that deliver a blend of heated and humidified gas mixture of air and oxygen at gas flows exceeding 1 L/ min via binasal cannula

Heated Humidified High-Flow Nasal Cannula therapy Group

nCPAP COMBINATION_PRODUCT

NCPAP will be provided by devices with pressure that is measurable and controllable that transport heated and humidified gas via binasal nasal prongs or nasal masks

N-CPAP Group

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• It includes
• All neonates with GA ≥28weeks
• Birth weight≥1000g
• RD occurred within 24 h after birth

You may not qualify if:

• Infants will be excluded from this study if they meet any of the following criteria:
• Major congenital anomalies or chromosomal abnormalities
• Suspected congenital lung diseases, malformations
• Neuromuscular disorders

Sponsors & Collaborators

• Pakistan Air Force (PAF) Hospital Islamabad: lead

Study Sites (1)

PAF Hospital Islamabad

Islamabad, Capital, 44000, Pakistan

Location

Related Publications (8)

• Kaminski DM, Biazus GF, Silveira RC, Procianoy RS. Comparison of the effectiveness of different high-flow devices in neonatal care. J Pediatr (Rio J). 2024 Mar-Apr;100(2):212-217. doi: 10.1016/j.jped.2023.10.006. Epub 2023 Nov 27.

  PMID: 38036038 RESULT

• Yengkhom R, Suryawanshi P, Gupta B, Deshpande S. Heated Humidified High-Flow Nasal Cannula vs. Nasal Continuous Positive Airway Pressure for Post-extubation Respiratory Support in Preterm Infants: A Randomized Controlled Trial. J Trop Pediatr. 2021 Jan 29;67(1):fmaa082. doi: 10.1093/tropej/fmaa082.

  PMID: 33174590 RESULT

• Ho JJ, Zakarija-Grkovic I, Lok JW, Lim E, Subramaniam P, Leong JJ. Continuous positive airway pressure (CPAP) for apnoea of prematurity. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD013660. doi: 10.1002/14651858.CD013660.pub2.

  PMID: 37481707 RESULT

• Sweet DG, Carnielli VP, Greisen G, Hallman M, Klebermass-Schrehof K, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update. Neonatology. 2023;120(1):3-23. doi: 10.1159/000528914. Epub 2023 Feb 15.

  PMID: 36863329 RESULT

• Lee WY, Choi EK, Shin J, Lee EH, Choi BM, Hong YS. Risk factors for treatment failure of heated humidified high-flow nasal cannula as an initial respiratory support in newborn infants with respiratory distress. Pediatr Neonatol. 2020 Apr;61(2):174-179. doi: 10.1016/j.pedneo.2019.09.004. Epub 2019 Sep 23.

  PMID: 31628028 RESULT

• Oktem A, Yigit S, Celik HT, Yurdakok M. Comparison of four different non-invasive respiratory support techniques as primary respiratory support in preterm infants. Turk J Pediatr. 2021;63(1):23-30. doi: 10.24953/turkjped.2021.01.003.

  PMID: 33686823 RESULT

• Pattnaik P, Adebisi K, Lee B. Neonatal Respiratory Distress Syndrome. 2026 Feb 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560779/

  PMID: 32809614 RESULT

• Liu J, Fu W, Qin SJ. Lung ultrasound to guide the administration of exogenous pulmonary surfactant in respiratory distress syndrome of newborn infants: A retrospective investigation study. Front Pediatr. 2022 Oct 12;10:952315. doi: 10.3389/fped.2022.952315. eCollection 2022.

  PMID: 36340730 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start: September 4, 2024
• Primary Completion: September 20, 2025
• Study Completion: September 20, 2025
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)