Sustained Lung Inflation in Preterm Infants

NCT ID: NCT03518762

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-21
• Study Completion Date: 2017-09-05

Brief Summary

This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.

Detailed Description

Enrolled infants (n=160) were randomized before birth into 2 groups (intervention and control group) in a ratio 1:1. Randomization was done through an online randomizer (www.graphpad.com), and sealed envelopes were used to assign the infant to one of the two groups.

Conditions

Preterm Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sustained lung inflation

Participants in this arm (n=80) received:

1. Sustained lung inflation (SLI) manoeuvre(s) was applied once or twice, based on the protocol algorithm.

Within the first 60 seconds of life, assessment for the need of advanced resuscitation (defined as the need for more than oxygen and tactile stimulation during resuscitation) was done;

• Infants who needed advanced resuscitation were considered to receive SLI as a rescue approach.
• Infants who needed only oxygen and tactile stimulation were considered to receive SLI as a prophylactic approach.

2. Then Continuous positive airway pressure (CPAP). Intermittent positive pressure ventilation (IPPV) was given through an ETT, if intubation was needed.

Group Type: EXPERIMENTAL

Sustained lung inflation (SLI)

Intervention Type: PROCEDURE

SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device

Continuous positive airway pressure (CPAP)

Intervention Type: PROCEDURE

CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.

Control

Participants in this arm (n=80) received:

1. Resuscitation according to the American academy of pediatrics guidelines.

2. Then Continuous positive airway pressure (CPAP). Intermittent positive pressure ventilation (IPPV) was given through an ETT, if intubation was needed.

Group Type: OTHER

Continuous positive airway pressure (CPAP)

Intervention Type: PROCEDURE

CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.

Interventions

Sustained lung inflation (SLI)

SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device

Intervention Type: PROCEDURE

Continuous positive airway pressure (CPAP)

CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Gestational age ≥ 27 weeks and ≤ 32 weeks
• Appropriate for gestational age
• Weight >800 grams

Exclusion Criteria

• Major congenital anomalies (congenital heart, cerebral, lung or abdominal malformations)
• Fetal hydrops

• Maximum Eligible Age: 1 Minute
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Douaa El Saied El Sherbiny

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasralainy Cairo University

Cairo, , Egypt

Countries

Egypt

References

Abuel Hamd WA, El Sherbiny DE, El Houchi SZ, Iskandar IF, Akmal DM. Sustained Lung Inflation in Pre-term Infants at Birth: A Randomized Controlled Trial. J Trop Pediatr. 2021 Jan 29;67(1):fmaa097. doi: 10.1093/tropej/fmaa097.

Reference Type: DERIVED

PMID: 33254237 (View on PubMed)

Other Identifiers

75381

Identifier Type: -

Identifier Source: org_study_id