Comparison of non-invasive treatment through the nose for the treatment of respiratory immaturity in preterm neonates

Early nasal intermittent positive pressure ventilation versus continuous positive airway pressure in preterm infants with respiratory distress syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014072618598N1

Enrollment

Registered

2015-09-25

Start date

2014-03-20

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 of newborn

Interventions

Intervention 1: Using of early nasal continous positive airway pressure at least 48 hours with the maximum positive end expiratory pressure: 5 cmH2o and Fio2: 60%. Intervention 2: Using of early nasal

Treatment - Other

Using of early nasal continous positive airway pressure at least 48 hours with the maximum positive end expiratory pressure: 5 cmH2o and Fio2: 60%

Using of early nasal intermittent positive pressure ventilating at least 48hours with the maximum PEEP: 5 cmH2o, Fio2: 60%, PIP: 16 cmH2o, Resirstory rate: 30/min

Eligibility

Sex/Gender

All

Age

1 Days to 1 Days

Inclusion criteria

Inclusion criteria: All consecutively born preterm infants with gestational age between 28 to 34 weeks, admitted to Fatemiyeh neonatal intensive care unit with respiratory distress syndrome Inclusion criteria: approved RDS; gestational age between 28 to 34 weeks; neonates with 72 hours age after delivery. Exclusioncriteria: the neonates aith APGAR score less than 3 at five minute after birth; those whom mother had rupture of the membrane for more than three weeks; severe malformation; chromosomal anomalies such as trisomy of 13,18 and 21; pneumonia; pneumothorax

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Survival rates in 7days. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: comparing survival rates.	—

Secondary

Measure	Time frame
Need to mechanical ventilation. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.;Lung hemorhage. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.;Pnemothorax. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.;NEC. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.;Sepsis. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.;Mortality. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.	—

Measure

Time frame

Need to mechanical ventilation. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.;Lung hemorhage. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.;Pnemothorax. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.;NEC. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.;Sepsis. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.;Mortality. Timepoint: during hospitalization and using NIPPV and NCPAP. Method of measurement: during hospitalization and using NIPPV and NCPAP.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamad Kazem Sabzehei

Hamedan University of Medical Sciences

Mk_sabzehei@yahoo.com+98 81 3838 0749

Outcome results

None listed

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