Comparing outcome of surfactant administration via tracheal catheterization during spontaneous breathing (tec-care) with tracheal intubation accompany with positive pressure ventilation (INSURE) in premature neonates with respiratory distress syndrome.
This study was designed to compare outcomes of two different procedure of surfactant administration in premature neonates with respiratory distress syndrome.The conventional method of surfactant administration( INSURE) is accompanied by tracheal intubation and positive pressure ventilation,but in the new method surfactant is delivered via a thin endotracheal catheter (TEC - Care), without termination Nasal CPAP . In this method surfactant is injected during delivery of Nasal CPAP with pressure of 8 to 10 cmh2o.This multi center study is going to be conducted concomitant within NICU of four university hospitals . Alzahra and 29 Bahman Hospital in Tabriz, Shahidbeheshti Hospital in Esfahan and Ommolbanin Hospital in Masshad during 6 months. At least 90 neonate are studied in each group. Including major eligibility objectives : newborns between 27 to 36 week gestational ages ; show clinical and radiographical evidences of RDS ; need care by Nasal CPAP and surfactant administration. Exclusion criteria are: Infants who have congenital abnormalities; Apgar score less than 6 in min 5.Our main aim of study is to compare incidence of bronchopulmonary dysplasia between two groups.
Other indicators that this study will measure for comparison between two groups are: Average hospitalization, Average duration of oxygen, Mechanical ventilation requirement, Incidence of intracranial hemorrhage, Frequency of pneumothorax, Next dose surfactant requirement and incidence of neonatal mortality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112078314N1
Registration date:2013-01-14, 1391/10/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-14, 1391/10/25
Registrant information
Name
Mohammad Heidarzadeh
Name of organization / entity
Health Ministry
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 7313
Email address
heidarzadeh@health.gov.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research,Tabriz University of Medical science
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing outcome of surfactant administration via tracheal catheterization during spontaneous breathing (tec-care) with tracheal intubation accompany with positive pressure ventilation (INSURE) in premature neonates with respiratory distress syndrome.
Public title
Comparing surfactant administration without intubation with conventional method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Neonates with gestational age of 27-36 weeks with respiratory distress syndrome that required surfactant administration; Delivered in Multi center hospitals of (Alzahra and 29 bahman from Tabriz; Ommolbanin from Mashhad and Shahid Beheshti from Esfehan); Were resuscitated according to resuscitation guide line 2006 .Exclusion criteria: Neonates with congenital disease ;Apgar score of less than 6 within 5 minutes .
Age
From 27 years old to 36 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
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
1
Registry name
No
Secondary trial Id
No
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Medical Faculty, Tabriz University of Medical Sciences,Golgasht street,Tabriz,East Azarbaijan,Iran
City
Tabriz
Postal code
Approval date
2012-04-16, 1391/01/28
Ethics committee reference number
91164
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome
ICD-10 code
P22
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Continuous positive airway pressure failure
Timepoint
Half-Hour after intervention
Method of measurement
Increasing respiratory distress syndrome score
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
Time of discharge from hospital
Method of measurement
Extracted from the file
2
Description
Intraventriculal hemorrhage
Timepoint
7th day after birth
Method of measurement
Cranial ultrasonography by a radiologist
3
Description
Chronic lung disease
Timepoint
36th week of gestational age
Method of measurement
Observation of hospital file for oxygen requirment at 36th weeks of postconceptional age
Intervention groups
1
Description
Clinical guideline for administering surfactant viaTEC-CARE:
1. NCPAP pressure should be increased as much as 8 to 10 cmh2o
2. In order to decrease secretions of the neonate we administer atropin 5ug/kg before intubation
3.The neonate is intubated by a 5f feeding tube.The tip of the catheter is guided through 1 to 2 cm below the vocal cords.
4. After placement the Feeding tube laryngoscope is removed from the mouth and surfactant is administrated slowly. Surfactant is injected slowly over 1 to 3 minutes.
5. If you require Fio2 over 40% readministration of Surfactants is possible.
a. During administration, the baby may be suffering from obstructive apnea then slowly stimulates the baby and increase the percentage of oxygen
b. Surfactant reflux into the infant's mouth will normal, it is recommended that if there is no acute respiratory failure suction secretions from baby's mouth should be avoided.
c.If sever respiratory failure accur and there is no response to stimulation and increased spo2 then ventilate the neonate with nasal prong or nasal mask or bag and mask and after recovery administer surfactant
d. After Surfactant administration return NCPAP pressure to 6cmh20
Category
Treatment - Devices
2
Description
Clinical Guide line for administering surfactant via INSURE:
1.Neonates are removed from NCPAP.
2. Before intubation 2μg / kg Fentanylwas injected for Sedation
3. Neonate is intubated with endotracheal tube appropriate to weight and gestational age then ensure for its proper place.
4. surfactant is administered by a 5f feeding tube
5.After intubation the neonate is ventilated for 1 min via bag and mask or T-Piece or ventilator until spo2 is more than 85%
6. Naloxone is administered 0.1 mg / kg.
7. Baby is Extubated
8. NCPAP is once again placed.
9. Assisted ventilation continues by NCPAP