surfactant administration via laryngeal mask airway versus endotracheal tube in severe neonatal respiratory distress syndrome

Surfactant administration via laryngeal mask airway (LMA) versus endotracheal tube in neonatal respiratory distress syndrome, a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201602019568N14

Enrollment

Registered

2016-03-10

Start date

2014-12-01

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 of newborn. Hyaline membrane disease

Interventions

Intervention 1: Intervention group: After inserting a size 1 Classic LMA using standard techniques, surfactant 2.5 ml/kg per dose was given in 2-4 aliquots to spontaneously breathing infants, at the d

the neonates were intubated and surfactant 2.5 ml/kg per dose was given via endotracheal tube in 2-4 aliquots.

Treatment - Drugs

Intervention group: After inserting a size 1 Classic LMA using standard techniques, surfactant 2.5 ml/kg per dose was given in 2-4 aliquots to spontaneously breathing infants, at the distal end of the

Control group: INSURE approach was used for surfactant delivery

Eligibility

Sex/Gender

All

Age

No minimum to 3 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: born at less than 37 gestational weeks, weighed = 1200 grams, had a diagnosis of RDS within the first two hours of life, requiring continuous positive airway pressure (CPAP) support = 5cm H2O (with or without nasal intermittent positive pressure ventilation (PPV)), plus fraction of inspired oxygen (FiO2) between 30 - 60% to maintain blood oxygen saturation (SpO2) between 88 to 95% Exclusion criteria: having a previous intubation, major malformations (craniofacial, cardiac or thoracic), mean arterial pressure (MAP) 60%, pneumothorax prior to enrollment, apnea requiring assisted ventilation, diaphragmatic hernia, and parents’ refusal to give informed consent.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The requirement for mechanical ventilation. Timepoint: One hour after surfactant treatment. Method of measurement: PH60, PO2<50 on the Arterial blood gas analysis.	—

Secondary

Measure	Time frame
Requirement for a second dose of surfactant. Timepoint: eight hours after surfactant administration. Method of measurement: Redosing was considered if FiO2 was = 60% or if FiO2 was = 30% associated with worsening of RDS clinical signs.;Reduced needed FiO2 to maintain adequate oxygenation. Timepoint: Before and one hour after surfactant therapy. Method of measurement: Determination of needed Fio2 in blender and by pulse oxymetry.	—

Measure

Time frame

Requirement for a second dose of surfactant. Timepoint: eight hours after surfactant administration. Method of measurement: Redosing was considered if FiO2 was = 60% or if FiO2 was = 30% associated with worsening of RDS clinical signs.;Reduced needed FiO2 to maintain adequate oxygenation. Timepoint: Before and one hour after surfactant therapy. Method of measurement: Determination of needed Fio2 in blender and by pulse oxymetry.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mahdi Sheikh

Maternal, Fetal and Neonatal Research Center

mahdisheikh@gmail.com+98 21 6659 1316

Outcome results

None listed

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