Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins Infants

NCT03235661 — Not applicable, Unknown, 300 participants, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins:A Randomized Controlled Trials

Registry	NCT03235661
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	300 (Estimated)
Sponsor	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)
Conditions	nCPAP, BiPAP, Respiratory Distress Syndrome
Interventions	BiPAP, nCPAP (Device)
Dates	start 2017-08-15, primary completion 2022-12-15 (estimated), completion 2022-12-15 (estimated), first posted 2017-08-01, last updated 2021-02-16
Locations	1 site in China

-Summary

The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -bi-level positive airway pressure(BiPAP) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome

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+Detailed description

Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of bi-level positive airway pressure(BiPAP) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.

+Arms and interventions

Arm	Type	Interventions	Description
BiPAP	Experimental	Device: BiPAP	BiPAP as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
nCPAP	Active comparator	Device: nCPAP	nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome

BiPAP (Device): BiPAP is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
nCPAP (Device): nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome

+Outcome measures

Primary outcomes

intubation rate [within 7 days]: the baby was intubated

+Eligibility

Sex: All, ages: 5 Minutes to 6 Hours

Inclusion Criteria:

* 1\. Gestational age (GA) is from 26 to 37 weeks;
* 2\. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
* 3\. Respiratory distress syndrome Silverman score >5;
* 4\. Informed parental consent has been obtained.

Exclusion Criteria:

* 1\. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
* 2\. Major congenital malformations or complex congenital heart disease;
* 3\. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
* 4\. Cardiopulmonary arrest needing prolonged resuscitation;
* 5\. transferred out of the neonatal intensive care unit without treatment.

+Locations (1)

Facility	City	Country	Status
Department of Pediatrics, Daping Hospital, Third Military Medical University	Chongqing, Chongqing Municipality	China	Recruiting

+Investigators

Shi Yuan, PhD,MD, Study director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University