Investigation of Noninvasive Cycled-PAP Efficacy in RDS Treatment

The Efficacy of Noninvasive Cycled-PAP in the Management of Respiratory Distress Syndrome in Infants with a Gestational Age of 28 to 32 Weeks: NIPPV Vs. Synchronized-NIPPV; A Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120728010430N12

Enrollment

Registered

2025-01-26

Start date

2023-08-23

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Shortage of surfactant causes RDS.. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group: For infants in the SNIPPV group, non-invasive ventilation parameters, including IPAP=dynamic pressure? EPAP=5 cm H2O? Ti=0.25”? pressure trigger=20%(dynamic pressur

In cases when an infant's need for inspiratory oxygen fraction remains higher than 40% to maintain oxygen saturation in an acceptable range, Beractant will be re-administered 6 hours after the previou

and non-invasive ventilation parameters, including IPAP=dynamic pressure, EPAP=5 cm H2O, Ti=0.45", and rate=25 bpm will be defined for the ventilator in IMV respiratory mode

In cases when an infant's nee

Eligibility

Sex/Gender

All

Age

1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Neonates with the gestational age of 28 to 32 weeks with regards to their clinical conditions and radiologic RDS being managed using nCPAP withing 2 hours after birth receiving surfactant through INSURE process Filling out the written consent forms

Exclusion criteria

Exclusion criteria: Evidence of chromosomal or genetic abnormalities significant congenital anomalies or malformations Any type of counter-indication causing limitations in implementing NIV (such as the need for surgical interventions in the digestive system) Evidence of perinatal asphyxia

Design outcomes

Primary

Measure	Time frame
Need for mechanical ventilation 72 hours after birth in preterm neonates suffering from RDS comparing SNIPPV and NIPPV administration. Timepoint: The period including 72 hours after birth. Method of measurement: Investigating arterial blood gases.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Sadeghnia

Esfahan University of Medical Sciences

sadeghnia@med.mui.ac.ir+98 31 3335 1777

Outcome results

None listed

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