Respiratory Distress Syndrome, Newborn
Conditions
Brief summary
This study aimed to determine the efficacy of different NCPAP weaning strategies in pre-term infants presenting with respiratory distress, and ultimately establishing the best method to withdraw from NCPAP.
Detailed description
Pakistan, as well as other developing countries, lacks data regarding the weaning protocol of NCPAP. Ascertaining the best weaning method that could facilitate a shorter duration on nasal CPAP and the least length of hospital stay is very much needed. Findings of this study would help clinicians to achieve better outcomes for the patients receiving nasal CPAP.
Interventions
PROCEDURESudden weaning of NCPAP
NCPAP was taken off entirely when the neonate met the stability criteria and remained on oxygen or room air via a headbox or incubator with an aim to stay off NCPAP.
PROCEDUREGradual weaning with increasing the time off NCPAP
The regimen adopted for this method was 1 hour off twice a day on the 1st day, then 2 hours off twice a day on the 2nd day, hence increasing the time off to 6 hours twice a day (or 12 hours per day), i.e., using a smaller period off. At this point, NCPAP was taken off completely.
PROCEDUREPressure weaning of NCPAP
In this method the pressure was reduced in steps of 1 cm of H2O every 12 to 24 hours until 5 cm of H2O, and then if the child tolerated it well, NCPAP was removed, and the child was shifted to oxygen via incubator or room air according to the situation.
Sponsors
RESnTEC, Institute of Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 24 Hours
Healthy volunteers
No
Inclusion criteria
* Preterm infants * Any gender * Low birth weight * Gestational ages between 28 to below 37 weeks * Presented with respiratory distress * Neonates with radiological findings suggestive of respiratory distress, congenital pneumonia/sepsis, or transient tachypnea of the newborn (TTN)
Exclusion criteria
* Complex congenital abnormalities like diaphragmatic hernia, CNS malformations, intrapartum-related hypoxia, or congenital heart disease. * Intraventricular hemorrhage grade III or IV or low APGAR scores (\<4 or 5 at 5 minutes)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful weaning | 4 days | Weaning was considered as successful in the absence of pronounced retractions, tachypnea, or episodes of apnea and if there was no requirement for ventilator support after cessation of NCPAP support. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of total days on NCPAP | 4 days | Total days on NCPAP for the three weaning strategies were measured from the start of NCPAP to the removal of NCPAP |
| Hospital stay | 25 days | Total days of hospital stay were measured from the admission to discharge from the hospital. |
Countries
Pakistan
Outcome results
None listed