Comparison of the efficacy and complication of humidified high flow nasal cannula versus nasal continuous positive airway pressure after treatment with surfactant in neonate with respiratory distress syndrome

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT201709049014N181
• Date of registration: 2017-09-07
• Prospective Registration: Yes
• Primary sponsor: Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
• Public title: Comparison of the efficacy and complication of humidified high flow nasal cannula versus nasal continuous positive airway pressure after treatment with surfactant in neonate with respiratory distress syndrome
• Scientific title: Comparison of the efficacy and complication of humidified high flow nasal cannula versus nasal continuous positive airway pressure after treatment with surfactant in neonate with respiratory distress syndrome: a randomized clinical trial
• Date of first enrolment: 2017-09-23
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://en.irct.ir/trial/9619
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.; Blinding: Not possible.
• Phase: 2

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr Mayam Shokoohi Solgi
• Affiliation: Sina Hospital

• Name: Dr Masoomeh Mahdiankhoo
• Affiliation: Sina Hospital

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: Age of 28 to 36 months; premature neonate; affecting with respiratory distress syndrome; hospitalization in NICU with 24 hours after birth.
Exclusion criteria: Being born in other hospitals.
Exclusion criteria:

Age minimum: 7 months
Age maximum: 9 months
Gender: Both

Health Condition(s) or Problem(s) studied

Adult respiratory distress syndrome.
Adult respiratory distress syndrome

Adult respiratory distress syndrome

Intervention(s)

Intervention 1: Intervention group: Treatment with surfactant 200 mg/kg for one week plus continuous positive airway pressure through the nasal mask with a pressure of 4 cm water and FIO2 equal to 40% for one week. Intervention 2: Control group: Treatment with surfactant 200 mg/kg plus humidified high flow through bilateral nasal cannula with a pressure of 2 liter per minute for one week.

Intervention group: Treatment with surfactant 200 mg/kg for one week plus continuous positive airway pressure through the nasal mask with a pressure of 4 cm water and FIO2 equal to 40% for one week.

Treatment - Drugs

Control group: Treatment with surfactant 200 mg/kg plus humidified high flow through bilateral nasal cannula with a pressure of 2 liter per minute for one week.

Treatment - Other

Primary Outcome(s)

The need for intubation. Timepoint: 72 hours after treatment. Method of measurement: with clinical examination.

Secondary Outcome(s)

Duration of admission. Timepoint: 72 hours after treatment. Method of measurement: according to medical records.

Number days required for respiratory protection. Timepoint: 72 hours after treatment. Method of measurement: based on clinical examination.

Source(s) of Monetary Support

Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Hamadan University of Medical Sciences