Study of two non-invasive ventilation methods in the treatment of acute respiratory distress syndrome of infants

Efficacy of continuous positive oscillatory nasal airway pressure versus continuous positive nasal airway pressure in neonates with 28-34 weeks of gestational age with respiratory distress syndrome: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016111930964N1

Enrollment

128

Registered

2016-12-30

Start date

2016-06-05

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 in new borns. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention 1: Eligible newborns were randomly allocated to the ‘Oscillatory NCPAP’ group. For this purpose, cno ncpap device ( made in Germany) was employed. Using this device, nasal

Treatment - Other

Intervention 1: Eligible newborns were randomly allocated to the ‘Oscillatory NCPAP’ group. For this purpose, cno ncpap device ( made in Germany) was employed. Using this device, nasal continuous posi

Intervention 2: Eligible newborns were randomly allocated to the ‘NCPAP’ group. For this purpose, sindi ncpap device (made in Germany) was employed. Using this device, nasal continuous positive airway

Eligibility

Sex/Gender

All

Age

No minimum to 1 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Preterm infants at gestational age of 28 to 34 weeks; weight between 1000 and 2000 grams; respiratory distress syndrome; Silverman-Anderson retraction score 6 - 7. Exclusion criteria: Congenital malformation; cardiac disease; severe asphyxia (Apgar score = 3 at 1 and 5 minute or pH = 7.12); parents' unwillingness to participate in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Non-invasive ventilatory failure. Timepoint: During first 72 hours of birth. Method of measurement: A questionnaire was used to investigate the noninvasive ventilation failure within first 72 hours of birth in which data were collected based on observation and ABG. The failure criteria were met by at least 1 of the following: pH = 7.20 and PaCO2 = 60 mm Hg, PaO2 = 50 mm Hg with a fraction of inspired oxygen = 0.6 or respiratory distress increase, recurrent apnea with = 3 episodes per hour associated with bradycardia, a single episode of apnea that required bag and mask ventilation.	—

Measure

Time frame

Non-invasive ventilatory failure. Timepoint: During first 72 hours of birth. Method of measurement: A questionnaire was used to investigate the noninvasive ventilation failure within first 72 hours of birth in which data were collected based on observation and ABG. The failure criteria were met by at least 1 of the following: pH = 7.20 and PaCO2 = 60 mm Hg, PaO2 = 50 mm Hg with a fraction of inspired oxygen = 0.6 or respiratory distress increase, recurrent apnea with = 3 episodes per hour associated with bradycardia, a single episode of apnea that required bag and mask ventilation.

—

Secondary

Measure	Time frame
Milk intolerance rate. Timepoint: Within admission period. Method of measurement: questionnaire.;Pneumothorax. Timepoint: Within first 72 h. Method of measurement: CXR.;IVH. Timepoint: At the end of first and fourth week or at the time of symptom incidence. Method of measurement: brain sonography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShiva Bashirnejad khabaz

Ahvaz Jundishapur University of Medical Sciences

bashirnejad.sh@ajums.ac.ir; sh.bashirnejad@gmail.com+98 613367543

Outcome results

None listed

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