The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03165305

Enrollment

200

Registered

2017-05-24

Start date

2018-04-01

Completion date

2019-06-01

Last updated

2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Newborn, Respiratory Morbidity, Transient Tachypnea of the Newborn

Brief summary

Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Therefore, the investigators hypothesized that SI performed just after birth may help to facilitate the transitional period and decrease the incidence of early respiratory morbidities such as transient tachypnea in term infants.

Interventions

OTHERSustained Inflation

Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Minutes

Healthy volunteers

Yes

Inclusion criteria

* term newborns * parental informed consent * inborn infants

Exclusion criteria

* major congenital/chromosomal abnormalities * lack of informed consent * outborn infants * Premature infants

Design outcomes

Primary

Measure	Time frame	Description
Respiratory Morbidity	2 hours	RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026