The use of headbox oxygen versus high flow nasal cannula (HFNC) for neonatal respiratory distress in non-tertiary hospitals

Not Applicable

• Conditions: Breathing support; Respiratory distress; Reproductive Health and Childbirth - Complications of newborn; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12611000233921
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

Diagnosed with respiratory distress. Defined as at least one of the following: intercostal/subcostal recession, audible ‘grunt’, or tachypnoea (respiratory rate >60/min).
2. Who require any supplemental inspired oxygen to maintain peripheral oxygen saturation (Sp02) of 90-95% for a period of more than one hour.
3. Aged less than 24 hours.

Exclusion Criteria

1. Gestational age at birth less than 32 completed weeks. The trial will continue to support and encourage the NHMRC recommendations for in utero transfer of infants expected to be born at less than 33weeks gestation. Furthermore, no change in practice will be made for those centres that routinely transfer in utero at gestational ages higher than 33 weeks. It is not uncommon, however, for babies of this gestation to be unavoidably born at a non-tertiary nursery.
2. Birth weight lower than that which the SCN would normally care for.
3. Apgar score less than or equal to 3 at 5 minutes of age (used as an arbitrary and de-facto indicator of possible perinatal asphyxia).
4. Any infant who is perceived by their paediatrician to need NICU care, or who has a known major congenital abnormality requiring care in a tertiary centre, or which may impact upon the infant’s condition after birth (eg. congenital cardiac disease, upper airway obstruction, gastrointestinal malformations).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment failure or transfer to tertiary centre.<br>Treatment failure will be deemed to have occurred if any ONE of the following failure criteria is met:<br>1. Supplemental oxygen requirement >40% to maintain Sp02 90-95% for more than one hour.<br>2. A carbon dioxide (CO2) level >60mmHg, persisting on two successive blood gases taken at least one hour apart.<br>3. A pH level <7.25, persisting on two successive gases at least one hour apart.[32 completed weeks post menstrual age]

Secondary Outcome Measures

Name	Time	Method
ength of time receiving supplemental oxygen[to hospital discharge];Total length of hospital admission[to hospital discharge];Incidence of pneumothorax (diagnosed on chest x-ray)[to hospital discharge];Parental satisfaction score using a likert scale.[to hospital discharge]