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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03235661
Enrollment
300
Registered
2017-08-01
Start date
2017-08-15
Completion date
2022-12-15
Last updated
2021-02-16

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

Conditions

nCPAP, BiPAP, Respiratory Distress Syndrome

Brief 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

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.

Interventions

DEVICEBiPAP

BiPAP is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome

DEVICEnCPAP

nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

BiPAP and nCPAP are used as primary mode of ventilation in preterm twins infants with RDS

Eligibility

Sex/Gender
ALL
Age
5 Minutes to 6 Hours
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
intubation ratewithin 7 daysthe baby was intubated

Countries

China

Contacts

Primary ContactMa Juan, MD
476679422@qq.com13883559467
Backup ContactMa Juan, MD
476679422@qq.com1388.559467

Outcome results

None listed

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