Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid and a common cause of admission of full term infants and late pre term infants (34 to 36 weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at delivery, and mode of delivery are considered risk factors for TTN. The investigators hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot study to evaluate the prophylactic administration of CPAP in the Delivery Room towards prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a randomized control trial after obtaining informed consents from the parents of eligible infants. Infants will be randomized to receive either experimental treatment (prophylactic CPAP) or standardized care.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fluid Management in Transient Tachypnea of the Newborn

NCT01225029

Transient Tachypnea of the Newborn

COMPLETED NA

Delivery Room CPAP in Extremely Low Birth Weight Infants

NCT01223274

Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age +3 more

COMPLETED PHASE1/PHASE2

High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation

NCT01270581

Transient Tachypnea of the Newborn

TERMINATED NA

Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM

NCT06123845

Respiratory Distress Syndrome in Premature Infant

RECRUITING NA

Study of Respiratory Physiology During High Flow Nasal Cannula Treatment in Preterm Neonates.

NCT02200900

Extreme Prematurity - Less Than 28 Weeks Respiratory Distress Syndrome in Premature Infants

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transient Tachypnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prophylactic CPAP intervention

Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff)

Group Type EXPERIMENTAL

Prophylactic CPAP Administration

Intervention Type OTHER

EXPERIMENTAL GROUP: Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the Delivery Room via T piece (Neopuff)

CONTROL GROUP: Provision of standard care in the Delivery Room

No Intervention

Provision of standard care in the Delivery Room

Group Type ACTIVE_COMPARATOR

Prophylactic CPAP Administration

Intervention Type OTHER

EXPERIMENTAL GROUP: Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the Delivery Room via T piece (Neopuff)

CONTROL GROUP: Provision of standard care in the Delivery Room

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prophylactic CPAP Administration

EXPERIMENTAL GROUP: Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the Delivery Room via T piece (Neopuff)

CONTROL GROUP: Provision of standard care in the Delivery Room

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Babies born to mothers via elective CS: elective CS defined as planned CS in the absence of Labor.
* Late preterm infants (34 1/7 to 36 6/7 weeks gestational age)

Exclusion Criteria

* Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥18 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization
* Need for use of PPV for perinatal depression or other indications
* Presence of any of the following

* congenital malformations (diagnosed prenatally)
* chromosomal anomalies (diagnosed prenatally)
* congenital heart disease diagnosed by fetal echocardiography.

Minimum Eligible Age

2 Minutes

Maximum Eligible Age

30 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes