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n-CPAP Versus n-BiPAP and NIPPV for Postextubation in RDS in Preterms

A

Ain Shams University

Status

Completed

Conditions

Respiratory Distress Syndrome

Treatments

Device: N-CPAP
Device: n-BiPAP
Device: NIPPV

Study type

Interventional

Funder types

Other

Identifiers

NCT01770925
Ain shams university
riham samy (Registry Identifier)

Details and patient eligibility

About

non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to compare between capap, n-bipap and NIPPV

Full description

The primary aim of this study is to compare the impact of early extubation to nasal continuous positive airway pressure (n-CPAP) versus nasal Bilevel positive airway pressure (n-BiPAP) and non invasive positive pressure ventilation(NIPPV) on the need for mechanical ventilation via endotracheal tube (MVET) to 7 days of age or less in preterm infants less than or equal to 34 weeks' gestation requiring intubation and surfactant if indicated for respiratory distress syndrome within 120 min of delivery . Second aim is to compare different outcomes of post-extubation n-CPAP , n-BiPAPand NIPPV.

Enrollment

120 patients

Sex

All

Ages

1 to 7 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • preterm infants lessthan 34wk

Exclusion criteria

  • preterms less than 1000 g birth weight
  • infants with apgar 0at 1 min
  • presenceofany other cause of respiratory distress as: congenital malformation affecting the cardiorespiratory system ,neuromuscular disease ,fetal hydrops , interventricular hemorrhage and chromosomal aberrations

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 3 patient groups

n-CPAP
Active Comparator group
Description:
The n-CPAP group will receive at extubation a single level continuous positive airway pressure of 7 cm water for at least 48 hours before weaning is commenced. If the infant is stable for the preceding 48 hours defined by having fewer than three minor apneas and no increase in oxygen requirement, weaning will be permitted. CPAP will be decreased from 6 cm water by 1 cm water every 24 hours if tolerated based on the above criteria. This will be done until a pressure of 4 cm water is reached. If a pressure of 4 cm water is successfully tolerated for 48 hours then time off n-CPAP will be allowed. Thereafter, no fixed weaning regime based on number of hours in a day the infant will be allowed to come off CPAP will be prescribed.
Treatment:
Device: N-CPAP
n-BiPAP
Active Comparator group
Description:
The n-BiPAP group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water). Inspiratory time of one second and respiratory rate of 30/min will always be maintained. The infant will then receive a mean airway pressure of 5 cm water (positive end expiratory pressure of 4 cm water and peak inspiratory pressure of 6 cm of water).
Treatment:
Device: n-BiPAP
NIPPV
Active Comparator group
Description:
o The NIPPV group will receive at extubation a positive end expiratory pressure of 5 cm water, peak inspiratory pressure of 15cm of water, RRof35 and Ti of 0.32
Treatment:
Device: NIPPV

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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