The effect of nasal prongs in the treatment of premature infants with respiratory distress syndrome

A comparative study of the use of CPAP with a nasal mask interface and CPAP with a Ram Cannula interface in the treatment of premature infants with a gestational age of 28 to 34 weeks with respiratory distress syndrome

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150423021910N9

Enrollment

Registered

2026-02-06

Start date

2026-02-04

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Respiratory distress syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group: Newborns born with a gestational age of 28-34 wk at Al-Zahra Medical Center (S) and Shahid Beheshti Hospital. These newborns must have manifestations based on respi

Initially, a positive pressure of 6 cm H2O (with a flow of 5 l/min) is defined for the infant. According to the optimal CDP indicators (elimination of grunting, decreased respiratory rate, decreased i

Eligibility

Sex/Gender

All

Age

1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Written parental consent Babies with a gestational age of 28-34 weeks Having clinical signs of respiratory distress syndrome (tachypnea, intercostal retraction, flaring of the nostrils, grunting, and need for an inhaled oxygen fraction greater than 21%) and a radiographic finding in favor of this disease

Exclusion criteria

Exclusion criteria: Congenital defects (congenital diaphragmatic hernia, tracheoesophageal fistula, Pierre-Robin sequence, Quan atresia) Poor respiratory effort, which can be accompanied by apnea or the need for invasive ventilation during NICU admission. Manifestations based on shock, pulmonary hemorrhage, persistent pulmonary hypertension Severe respiratory acidosis Severe metabolic acidosis Parental non-consent to the study

Design outcomes

Primary

Measure	Time frame
Duration of CPAP. Timepoint: End of study. Method of measurement: Researcher-made questionnaire.	—

Secondary

Measure	Time frame
Duration of oxygen intake. Timepoint: End of study. Method of measurement: Researcher-made questionnaire.;Pneumothorax. Timepoint: End of study. Method of measurement: Researcher-made questionnaire.;Number of prescribed doses of surfactant. Timepoint: End of study. Method of measurement: Researcher-made questionnaire.;Need for mechanical ventilation. Timepoint: End of study. Method of measurement: Researcher-made questionnaire.	—

Measure

Time frame

Duration of oxygen intake. Timepoint: End of study. Method of measurement: Researcher-made questionnaire.;Pneumothorax. Timepoint: End of study. Method of measurement: Researcher-made questionnaire.;Number of prescribed doses of surfactant. Timepoint: End of study. Method of measurement: Researcher-made questionnaire.;Need for mechanical ventilation. Timepoint: End of study. Method of measurement: Researcher-made questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehzad Barekatain

Esfahan University of Medical Sciences

b_barekatain@med.mui.ac.ir+98 31 3386 8247

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026