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

M

Mansoura University Children Hospital

Status

Completed

Conditions

Prematurity, Mechanical Ventilation

Treatments

Device: HHHFNC 6 liter minute
Device: HHHFNC 3 liters/min

Study type

Interventional

Funder types

Other

Identifiers

NCT02681315
MS/15.10.41

Details and patient eligibility

About

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.

Full description

HHHFNC has been proposed as an alternative to nasal continuous positive airway pressure (nCPAP) in neonatal intensive care units (NICUs) for preventing extubation failure. In a recent international survey on periextubation practices in extremely preterm infants, nCPAP was the most common type of respiratory support used (84%) followed by nasal intermittent positive pressure ventilation (55%) and HHHFNC (33%). Moreover, HHHFNC appears to have efficacy and safety similar to those of nCPAP when applied immediately post-extubation to prevent extubation failure in preterm infants. and resulted in significantly less nasal trauma in the first 7 days post-extubation than nCPAP. However, the best flow rates of HHHFNC to prevent extubation failure remains to be known. This RCT aims to compare the efficacy and safety of postextubation respiratory support via HHHFNC at two different flow rates (6 L/min. versus 3 L/min) regarding successful extubation after a period of endotracheal positive pressure ventilation. We hypothesized that postextubation respiratory support via HHHFNC at a flow rate of 6 L/min. will result in a greater proportion of preterm infants being successfully extubated after a period of endotracheal positive pressure ventilation compared with HHHFNC at a flow rate of 3 L/min.

Enrollment

40 patients

Sex

All

Ages

1 hour to 30 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

6 liter/min group
Experimental group
Description:
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.
Treatment:
Device: HHHFNC 6 liter minute
3 liter/min group
Active Comparator group
Description:
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.
Treatment:
Device: HHHFNC 3 liters/min

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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