Comparison of the effect of surfactant administration during NCPAP with NCPAP alone on mortality ,morbidity and complications of RDS in premature neonates
The aim of this study is to compare the effect of administration of surfactant during nasal continuous positive airway pressure (nCPAP) with only early CPAP administration for premature infants with RDS. This is a controlled randomized clinical trial on 60 premature neonates who are transported from Imam Khomeiny maternity Hospital to the NICU of Bu-Ali Hospital. Neonates with gestational age less than 35 weeks, age less or equal to 12hours after birth and the presence of symptoms of respiratory distress are placed on nCPAP and then randomly assigned to intubation and intratracheal administration of surfactant or treatment with nCPAP alone. The exclusion criteria are intubation before reaching Bu-Ali Hospital and signs and symptoms of chorioamnionitis in mother.
The primary outcome is the need for mechanical ventilation on the basis of our defined criteria and the secondary outcomes are the neonatal mortality, duration of hospital stay, the incidence of intracranial hemorrhage, pulmonary hemorrhage, chronic lung disease, duration of requirement for mechanical ventilation and oxygen therapy, need for resque surfactant treatment and the number of administered doses of surfactant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205213512N2
Registration date:2012-06-18, 1391/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-18, 1391/03/29
Registrant information
Name
Maryam Nakhshab
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1321 0853
Email address
mnakhshab@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of surfactant administration during NCPAP with NCPAP alone on mortality ,morbidity and complications of RDS in premature neonates
Public title
The effect of the use of surfactant administration during NCPAP treatment on complications of RDS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: gestational age less than 35 weeks; age less or equal to 12 hours after birth; the presence of symptoms of respiratory distress syndrom (RDS); symptoms begun in the first 6 hours after birth; radiologic signs for RDS in chest radiography. The exclusion criteria: 5 minutes Apgar score less than 6; intubation before reaching Bu-Ali Hospital, presence of major anomalies, PROM> 12 hours, admission to Bu-Ali Hospital after 12 hours of age, signs and symptoms of chorioamnionitis in mother, beginning of respiratory distress after 6 hours of birth, need for mechanical ventilation (on the basis of our defined criteria) at the time the patient reaches to Bu-Ali Hospital.
Age
To 1 year 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Vice-Chancellor for Research, Moalem sq., Sari, Mazandaran, Iran
City
Sari
Postal code
Approval date
2011-03-02, 1389/12/11
Ethics committee reference number
89-166
Health conditions studied
1
Description of health condition studied
Respiratory Distress Syndrome in the newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory Distress syndrome
Primary outcomes
1
Description
need for mechanical ventilation
Timepoint
daily within the first week of life
Method of measurement
physical exam for significant respiratory distress and/or the presence of persistent or recurrent apnea and check of ABG for hypoxia or respiratory acidosis .
Secondary outcomes
1
Description
neonatal mortality
Timepoint
during hospitalization
Method of measurement
hospital documents
2
Description
duration of hospital stay
Timepoint
during of hospitalization
Method of measurement
hospital documents
3
Description
the incidence of pneumothorax
Timepoint
till 72 hours after birth
Method of measurement
CXR
4
Description
pulmonary hemorrhage
Timepoint
till 72 hours after birth
Method of measurement
cilinical diagnosis and CXR
5
Description
number of rescue doses of surfactant
Timepoint
till 48 hours after birth
Method of measurement
hospital documents
6
Description
the incidence of chronic lung disease (CLD)
Timepoint
till 36 weeks’ postnatal age
Method of measurement
oxygen requirement at 36 weeks’ postnatal age
7
Description
intraventricular hemorrhage (IVH)
Timepoint
7-14 days after birth
Method of measurement
brain sonography
8
Description
periventricular leukomalacia (PVL)
Timepoint
between 36 and 40 weeks; postnatal age
Method of measurement
brain sonography
9
Description
the incidence of retinopathy of prematurity
Timepoint
4 weeks' of age and then every week till vascularization is completed
Method of measurement
eye exam
10
Description
duration of mechanical ventilation
Timepoint
during hospital stay
Method of measurement
hospital documents
11
Description
duration of need for oxygen
Timepoint
during hospital stay
Method of measurement
hospital documents
Intervention groups
1
Description
In control group nasal CPAP of 6 cm H2O is administered for the patients and the infant remains on NCPAP.Any patient who needs mechanical ventilation (according to criteria below) is intubated and placed under intermittent mandatory ventilation (IMV) and is considered as nCPAP failure in control group. If needed Fio2 is more than 30% the resque dose of surfactant (Survanta ) is administered. Additional surfactant doses are given every 6 hours as long as Fio2 remains more than 30% but not after 48 hours of age
Category
Treatment - Devices
2
Description
In the treatment group the patient is placed on nCPAP and then temporarily intubated. A natural surfactant (Survanta , Abbot Laboratories, Abbot Park, IL) 100 mg/Kg is administered intratrachealy and the neonate is ventilated manually with Neopuff infant resuscitator (Fisher & Paykel Healthcare, Inc, Auckland, New Zealand) with peak inspiratory pressure of 20 cm H2O and positive-end expiratory pressure of 5 cm H2O only for some minutes and if the patient is stable extubation to NCPAP of 5 cm H2O is accomplished. Every patient on CPAP would receive Aminophylline with a loading dose of 5 mg/Kg and then 1 mg/Kg every 8 hour intravenously.
Any patient who needs mechanical ventilation is intubated and placed under intermittent mandatory ventilation (IMV) and is considered as INSURE failure in treatment group . If needed Fio2 is more than 30% the resque dose of surfactant (Survanta ) is administered. Additional surfactant doses are given every 6 hours as long as Fio2 remains more than 30% but not after 48 hours of age.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Hospital
Full name of responsible person
Maryam Nakhshab
Street address
Bu-Ali Hospital, Sari, Mazandaran, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Siences
Full name of responsible person
Ahmad Ali Enayati
Street address
Mazandaran University of Medical Siences, Moalem Sq., Sari, Mazandaran, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Siences
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
Mazandaran University of Medical Siences
Full name of responsible person
Maryam Nakhshab
Position
assisstant professor/MD
Other areas of specialty/work
Street address
Bu-Ali Hospital, Sari, Mazandaran, Iran
City
sari
Postal code
Phone
+98 15 1321 0853
Fax
Email
mnakhshab@mazums.ac.ir pegahch@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandran University of Medical Siences
Full name of responsible person
Maryam Nakhshab
Position
assisstant professor/MD
Other areas of specialty/work
Street address
BuAli Hospital, Sari, Mazandran, Iran
City
Sari
Postal code
Phone
+98 15 1321 0853
Fax
Email
mnakhshab@mazums.ac.ir pegahch@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Siences
Full name of responsible person
Maryam Nakhshab
Position
Assistant professor /MD
Other areas of specialty/work
Street address
BuAli Hospital, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 15 1321 0853
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)