Continuous positive airway pressure in premature infants with respiratory distress syndrome

Comparison of Bubble CPAP with Variable CPAP in respiratory distress syndrome in preterm infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014081918862N1

Enrollment

Registered

2014-09-27

Start date

2013-04-05

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

respiratory distress syndrome of preterm neonates. Respiratory distress syndrome of newborn

Interventions

Intervention 1: CPAP by under water Bubble CPAP system (Fisher & Paykel Healthcare, Auckland 2013 Panmure, Auckland 1741 New Zealand). Intervention 2: NCPAP with Medijet (Medijet active NCPAP Generato

Treatment - Devices

CPAP by under water Bubble CPAP system (Fisher & Paykel Healthcare, Auckland 2013 Panmure, Auckland 1741 New Zealand)

NCPAP with Medijet (Medijet active NCPAP Generator, Medin Innovations GmbH Lindberghstrasse Ikaruspark D - 82178 Puchheim)

Eligibility

Sex/Gender

All

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Gestational age of 28-34 weeks; Birth weight 1000-2400 g; Respiratory distress syndrome; Respiratory score 5-7 under the Table Silverman Anderson Exclusion criteria: Infants with congenital malformations including congenital heart disease, congenital diaphragmatic hernia, esophageal atresia, cleft lip and palate, Gastrochesia, emphalocele and gastrointestinal obstruction ; Moderate to severe asphyxia (II,III); Clinical signs of infection; Hematocrit less than 35; ICH , IVH (III.IV); Lack of parental consent

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Duration of CPAP. Timepoint: 12 to 24 hour and during daily visits. Method of measurement: PEEP Pressure , Fio2.;Duration of mechanical ventilation. Timepoint: 12 to 24 hour and during daily visits. Method of measurement: PIP , Fio2 , PEEP , RR.;Duration of Oxygen with Hood. Timepoint: 12 to 24 hour and during daily visits. Method of measurement: Fio2.	—

Secondary

Measure	Time frame
Incidence of complications ( IVH,PDA,Pneumothorax). Timepoint: Daily until discharge. Method of measurement: IVH with brain sonography, PDA with echocardiography,Pneumothorax with CXR or transilumination.;Weight gain at discharge. Timepoint: Daily until discharge. Method of measurement: scale.;Duration of Hospitalization. Timepoint: Daily until discharge. Method of measurement: date.;Death. Timepoint: Daily until discharge. Method of measurement: Physical exam.	—

Measure

Time frame

Incidence of complications ( IVH,PDA,Pneumothorax). Timepoint: Daily until discharge. Method of measurement: IVH with brain sonography, PDA with echocardiography,Pneumothorax with CXR or transilumination.;Weight gain at discharge. Timepoint: Daily until discharge. Method of measurement: scale.;Duration of Hospitalization. Timepoint: Daily until discharge. Method of measurement: date.;Death. Timepoint: Daily until discharge. Method of measurement: Physical exam.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohsen Karimi

Shahid Sadoughi University of Medical Sciences

mohsensr853@Yahoo.Com+98 35 1724 0171

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026