Comparing two respiratory support methods in RDS treatment of premature neonates

Comparison of Continuous Positive Airway Pressure (CPAP) and Heated Humidified High Flow Nasal Cannula (HFNC) methods in treatment of neonates with respiratory distress syndrome with gestational age 28-34 weeks

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200616047788N1

Enrollment

120

Registered

2020-07-21

Start date

2020-06-21

Completion date

Unknown

Last updated

2020-08-17

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

Conditions

neonatal respiratory distress syndrome.

Interventions

Intervention 1: In the CPAP group we will use Fabian CPAP PLUS ( Acutronic medical system, Switzerland) and Fisher & Paykel humidifiers (Auckland, News land). patients will receive positive end-expira

Eligibility

Sex/Gender

All

Age

1 Days to 7 Days

Inclusion criteria

Inclusion criteria: All preterm newborns with gestational age 28 -34 weeks, admitted to Imam Khomeini hospital, Ahvaz, 2020-2021

Exclusion criteria

Exclusion criteria: major congenital anomaly, cyanotic congenital heart disease, neuromuscular disease, sepsis, congenital pneumonia, inborn errors of metabolism, meconium aspiration syndrome, perinatal asphyxia, APGAR score=< 5 at 5 minutes, intubation at birth or prolonged positive ventilation at the delivery room, severe RDS necessitating intubation at birth based on NRP guidelines, severe cardiovascular instability, absence of spontaneous respiration and recurrent apnea, no respiratory distress.

Design outcomes

Primary

Measure	Time frame
All premature infants with RDS sore <8. Timepoint: Rds score prior and after intervention. Method of measurement: Modified Downe's scoring system.	—

Secondary

Measure	Time frame
Need to intubation during first 72 hours of birth. Timepoint: third day of life. Method of measurement: physical examination, ABG, pulse oxymetry.;Intraventricular hemorrhage. Timepoint: from birth to discharge if complications associated with IVH appear ( Anemia, a decrease of consciousness, change of vital signs). Method of measurement: brain sonography.;Chronic lung disease. Timepoint: day 28 of life. Method of measurement: need to Fio2> 21%.;Patent ductus arteriosus requiring medical treatment. Timepoint: from 3rd to 7th day of life if symptoms associated with PDA appear( need to a higher fio2 , bounding pulses). Method of measurement: echocardiography.;Air leak syndromes. Timepoint: from birth until receiving CPAP or HFNC. Method of measurement: physical examination, CXR.	—

Measure

Time frame

Need to intubation during first 72 hours of birth. Timepoint: third day of life. Method of measurement: physical examination, ABG, pulse oxymetry.;Intraventricular hemorrhage. Timepoint: from birth to discharge if complications associated with IVH appear ( Anemia, a decrease of consciousness, change of vital signs). Method of measurement: brain sonography.;Chronic lung disease. Timepoint: day 28 of life. Method of measurement: need to Fio2> 21%.;Patent ductus arteriosus requiring medical treatment. Timepoint: from 3rd to 7th day of life if symptoms associated with PDA appear( need to a higher fio2 , bounding pulses). Method of measurement: echocardiography.;Air leak syndromes. Timepoint: from birth until receiving CPAP or HFNC. Method of measurement: physical examination, CXR.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammd Reza Aramesh

Ahvaz University of Medical Sciences

Aramesh-m@ajums.ac.ir+98 61 3222 6104

Outcome results

None listed

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