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

NCT ID: NCT01770925

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-05-01

Brief Summary

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

Detailed 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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

n-CPAP

• 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.

Group Type: ACTIVE_COMPARATOR

N-CPAP

Intervention Type: DEVICE

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.

n-BiPAP

• 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).

Group Type: ACTIVE_COMPARATOR

n-BiPAP

Intervention Type: DEVICE

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).

NIPPV

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

Group Type: ACTIVE_COMPARATOR

NIPPV

Intervention Type: DEVICE

The NIPPV group will receive at extubation a positive end expiratory pressure of 5 cm water , a peak inspiratory pressure of 9 cm of water, RR of 35 and ti of 0.32

Interventions

N-CPAP

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.

Intervention Type: DEVICE

n-BiPAP

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).

Intervention Type: DEVICE

NIPPV

The NIPPV group will receive at extubation a positive end expiratory pressure of 5 cm water , a peak inspiratory pressure of 9 cm of water, RR of 35 and ti of 0.32

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Rania Ali El-Farrash

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania EL-Farrash, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of paediatrics Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

riham samy

Identifier Type: REGISTRY

Identifier Source: secondary_id

Ain shams university

Identifier Type: -

Identifier Source: org_study_id