Comparison of efficacy and complications of bubble –CPAP with Ventilatory –CPAP in preterm infants with respiratory distress admitted in NICU Afzalipour Medical Center, Kerman, Iran.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138902083250N2

Enrollment

Registered

2010-05-11

Start date

2009-12-22

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

Treatment. Respiratory distress syndrom of newborns

Interventions

Intervention 1: Intervention-Bubble CPAP. Intervention 2: Intervention- Ventilatory CPAP.

Treatment - Devices

Intervention-Bubble CPAP

Intervention- Ventilatory CPAP

Eligibility

Sex/Gender

All

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All consecutively born preterm infants with birth weight between 1000 to 2000 grams, admitted to Afzalipour neonatal intensive care unit with respiratory distress and Silverman-Anderson retraction score of 6 and 7 were included. Exclusion criteria: Babies were excluded if there was significant morbidity apart from RDS including cardiac diseasse, congenital malformation including congenital diapheragmatic hernia, tracheoesophageal fistula and cleft lip/palate; babies with respiratory distress secondary to severe asphyxia (Apgar score<3 at 1&5 minute or PH<7.12) or if they had cardiovascular or respiratory instability because of sepsis, anemia or severe intraventricular hemorrhage (IVH) on admission.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Response to treatment. Timepoint: During hospitalization and using CPAP. Method of measurement: Comparing survival rates.	—

Secondary

Measure	Time frame
Incidence of pneumothorax. Timepoint: During hospitalization and using CPAP. Method of measurement: Taking chest X rays on admission and deterioration of clinical status.;Incidence of PDA. Timepoint: During hospitalization and using CPAP. Method of measurement: Echocardiography on admission and deterioration of clinical status.;Incidence of IVH. Timepoint: During hospitalization and using CPAP. Method of measurement: Cranial Ultrasonography on admission and deterioration of clinical status.;Incidence of chronic lung disease. Timepoint: During hospitalization. Method of measurement: Taking chest X rays on admission and winning.;Incidence of trauma to nasal septum and nostrils. Timepoint: During using Cpap. Method of measurement: Physical examination by an expert neonatalogist.	—

Measure

Time frame

Incidence of pneumothorax. Timepoint: During hospitalization and using CPAP. Method of measurement: Taking chest X rays on admission and deterioration of clinical status.;Incidence of PDA. Timepoint: During hospitalization and using CPAP. Method of measurement: Echocardiography on admission and deterioration of clinical status.;Incidence of IVH. Timepoint: During hospitalization and using CPAP. Method of measurement: Cranial Ultrasonography on admission and deterioration of clinical status.;Incidence of chronic lung disease. Timepoint: During hospitalization. Method of measurement: Taking chest X rays on admission and winning.;Incidence of trauma to nasal septum and nostrils. Timepoint: During using Cpap. Method of measurement: Physical examination by an expert neonatalogist.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArash Malekiyan

Kerman University of Medical sciences

malekianarash@yahoo.com+98 34 1322 2269

Outcome results

None listed

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