Surfactant administration via laryngeal mask airway (LMA) versus endotracheal tube in neonatal respiratory distress syndrome, a randomized controlled trial
In a randomized clinical trial, 60 preterm neonates with gestation age 29-37 weeks who were diagnosed with respiratory distress syndrome and require surfactant treatment, will be randomly allocated to two groups. Thirty neonates receive surfactant via endotracheal tube and 30 via laryngeal mask. Then patients will be extubated. We follow patients with respect to the need for FiO2 to maintain normal O2 saturation and need for intubation and assisted ventilation during the first 3 days after surfactant therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602019568N14
Registration date:2016-03-10, 1394/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-10, 1394/12/20
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of the Tehran University of Medical Sciences
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2015-12-30, 1394/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surfactant administration via laryngeal mask airway (LMA) versus endotracheal tube in neonatal respiratory distress syndrome, a randomized controlled trial
Public title
surfactant administration via laryngeal mask airway versus endotracheal tube in severe neonatal respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion 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) < 40 mmHg, Apgar score ≤ 3 at 5 minutes, requiring FiO2 concentrations > 60%, pneumothorax prior to enrollment, apnea requiring assisted ventilation, diaphragmatic hernia, and parents’ refusal to give informed consent.
Age
To 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee of the Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab Street
City
Tehran
Postal code
Approval date
2015-05-10, 1394/02/20
Ethics committee reference number
IR.TUMS.REC.1394.2027
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22.0
ICD-10 code description
Hyaline membrane disease
Primary outcomes
1
Description
The requirement for mechanical ventilation
Timepoint
One hour after surfactant treatment
Method of measurement
PH<7.15, PCO2>60, PO2<50 on the Arterial blood gas analysis
Secondary outcomes
1
Description
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.
2
Description
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
Intervention groups
1
Description
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 LMA using a shortened 5 French-feeding catheter.
Category
Treatment - Drugs
2
Description
Control group: INSURE approach was used for surfactant delivery; the neonates were intubated and surfactant 2.5 ml/kg per dose was given via endotracheal tube in 2-4 aliquots.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-asr hospital
Full name of responsible person
Dr. Sajjad Nourollahi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Golnaz Rezaeizadeh
Street address
Maternal, Fetal and Neonatal Research Center, Vali-asr Hospital, Imam Khomeini Hospital complexes, Keshavarz blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Maternal, Fetal and Neonatal Research Center
Full name of responsible person
Dr. Mahdi Sheikh
Position
Researcher
Other areas of specialty/work
Street address
Maternal, Fetal and Neonatal Research Center, Vali-asr Hospital, Imam Khomeini Hospital complexes, Keshavarz blvd
City
Tehran
Postal code
Phone
+98 21 6659 1316
Fax
Email
mahdisheikh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Elaheh Amini
Position
Associate Professor
Other areas of specialty/work
Street address
Maternal, Fetal and Neonatal Research Center, Vali-asr Hospital, Imam Khomeini Hospital complexes, Keshavarz blvd
City
Tehran
Postal code
Phone
+212 2142923
Fax
Email
el88_amini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi Sheikh
Position
Researcher
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)