Comparison of Two Flow Rates of HHHFNC to Prevent Extubation Failure in Preterm Infants

NCT02681315 | Completed DMC

• 1 other identifier: MS/15.10.41
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial (RCT) to evaluate the influence of two flow rates (6 liter/min versus 3 liter/min) of Heated-Humidified High-Flow-Nasal-Cannula (HHHFNC) on rates of extubation failure in mechanically ventilated preterm infants.

Conditions

Prematurity, Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Extubation failure

  Extubation failure criteria will be defined as follows: 1. Apnea (respiratory pause \>20 seconds), more than 6 episodes requiring physical stimulation in 6 hours or 1 requiring intermittent positive pressure ventilation. 2. Respiratory acidosis with pH \<7.25 and Peripheral arterial oxygen saturation (PaCO2) \>65 mmHg. ( \>15% sustained increase in FiO2 from extubation. 4. Cardiovascular collapse (heart rate \<60 beats per minute or shock. 5. Persistent marked/severe retractions. Extubation failure will be deemed to occur if any single criterion was met in any one of the 7 days after extubation. The decision to reintubate an infant and mechanical ventilation variables and subsequent extubation attempts after reintubation will be managed at the discretion of the clinical team.

  the 7 days after extubation

Secondary Outcomes (8)

• Mortality

  within the 96 hour post-extubation period or at any time after with expected average of 5 weeks

• Total duration of mechanical ventilation

  During NICU admission with expected average of 5 weeks

• Total duration of oxygen supplementation

  During NICU admission with expected average of 5 weeks

• Bronchopulmonary dysplasia (BPD)

  at 36 weeks' post-menstrual age.

• Severe BPD

  at 36 weeks' post-menstrual age.

Study Arms (2)

6 liter/min group

EXPERIMENTAL

Infants will be extubated to a HHHFNC (Fisher and Paykel Healthcare , Auckland, New Zealand) at flow rate of 6 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.

Device: HHHFNC 6 liter minute

3 liter/min group

ACTIVE COMPARATOR

Infants will be extubated to HHHFNC (Fisher and Paykel Healthcare , Auckland, New Zealand) a flow rate of 3 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.

Device: HHHFNC 3 liters/min

Interventions

HHHFNC 6 liter minute DEVICE

Infants allocated to HHHFNC at 6 L/min. will be extubated to a HHHFNC flow of 6 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.

6 liter/min group

HHHFNC 3 liters/min DEVICE

Infants allocated to HHHFNC at 3 L/min. will be extubated to a HHHFNC flow of 3 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.

3 liter/min group

Eligibility Criteria

• Age: 1 Hour - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born at less than 37 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and are considered ready for extubation by the clinical team. Infants will be enrolled after written informed parental consent is obtained.

You may not qualify if:

• Suspected upper airway obstruction, congenital airway malformations, or major cardiopulmonary malformations

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Neonatal Intensive Care Unit, Mansoura University Children Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (4)

• Al-Mandari H, Shalish W, Dempsey E, Keszler M, Davis PG, Sant'Anna G. International survey on periextubation practices in extremely preterm infants. Arch Dis Child Fetal Neonatal Ed. 2015 Sep;100(5):F428-31. doi: 10.1136/archdischild-2015-308549. Epub 2015 Jun 10.

  PMID: 26063193 BACKGROUND

• Collaborative Group for the Multicenter Study on Heated Humidified High-flow Nasal Cannula Ventilation. [Efficacy and safety of heated humidified high-flow nasal cannula for prevention of extubation failure in neonates]. Zhonghua Er Ke Za Zhi. 2014 Apr;52(4):271-6. Chinese.

  PMID: 24915914 BACKGROUND

• Collins CL, Holberton JR, Barfield C, Davis PG. A randomized controlled trial to compare heated humidified high-flow nasal cannulae with nasal continuous positive airway pressure postextubation in premature infants. J Pediatr. 2013 May;162(5):949-54.e1. doi: 10.1016/j.jpeds.2012.11.016. Epub 2012 Dec 20.

  PMID: 23260098 BACKGROUND

• Collins CL, Barfield C, Horne RS, Davis PG. A comparison of nasal trauma in preterm infants extubated to either heated humidified high-flow nasal cannulae or nasal continuous positive airway pressure. Eur J Pediatr. 2014 Feb;173(2):181-6. doi: 10.1007/s00431-013-2139-8. Epub 2013 Aug 18.

  PMID: 23955516 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hesham Abdel-Hady

  Mansoura University Children"s Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 12, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 25, 2020

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)