Investigation of efficacy rate of prophylactic treatment with oral paracetamol for closure of patent ductus arteriosus in preterm infants admitted in neonatal intensive care unit
The aim of the study is investigating the efficacy rate of prophylactic treatment with oral paracetamol for closure of patent ductus arteriosus in preterm infants. Inclusion criteria is premature neonates born at or before 32 weeks of gestation with birth weight less than or equal to 1500 grams and exclusion criteria is congenital major anomalies or chromosomal abnormalities. This interventional study will performed in premature newborns who admitted in neonatal intensive care unit of Vali-e-Asr Hospital in 2012-2013. Since thus far no studies have been conducted about the efficacy of acetaminophen for closure of patent ductus arteriosus, so 30 subjects are evaluated in this study. Subjects are randomly divided into 2 groups at beginning of admission. For the first group during first 24 hours after birth 15mg/kg oral acetaminophen will administrated every 6 hours for 48 hours. Echocardiography will performed for them during 24-36 hours after the last dose of acetaminophen by a pediatric cardiologist to evaluating of ductus arteriosus. Echocardiography of newborns in second group will also performed during 4-5 days old without any intervention by the same specialist to evaluate ductus arteriosus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090519050N1
Registration date:2015-02-02, 1393/11/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-02, 1393/11/13
Registrant information
Name
Mohammad Reza Zarkesh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 7764
Email address
zarkesh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran university of medical sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of efficacy rate of prophylactic treatment with oral paracetamol for closure of patent ductus arteriosus in preterm infants admitted in neonatal intensive care unit
Public title
The efficacy of prophylactic treatment with oral acetaminophen for closure of patent ductus arteriosus in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Premature neonates born at or before 32 weeks of gestation with birth weight less than or equal to 1500 grams admitted in neonatal intensive care unit of Vali-e-Asr Hospital in 2012; parental consent for participating in this study. Exclusion criteria: Newborns with congenital heart defects that patency of ductus arteriosus is vital for them such as pulmonary atresia; congenital major anomalies or chromosomal abnormalities; maternal consumption of none steroidal anti-inflammatory drugs during pregnancy; newborns with hydrops fetalis or persistent pulmonary hypertension of the newborn; apgar score less than 5 at fifth minute after birth; appearance of patent of dutus arteriosus symptoms and requirement for treatment with Ibuprofen at any time; having vomiting or hematemesis during first 3 days after birth; neonates with glucose-6-phosphate dehydrogenase deficiency based on blood exam at beginning of neonatal admission
Age
To 6 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
The Ethical Committee of Tehran University of Medical Science
Street address
The Ethical Committee of Tehran University of Medical Science, Vice Chancellor for research, 6th Floor, Tehran University of Medical Sciences, Corner of Ghodss Street, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2013-08-04, 1392/05/13
Ethics committee reference number
905/130/د/92
Health conditions studied
1
Description of health condition studied
patent ductus arteriosus
ICD-10 code
Q25.0
ICD-10 code description
Congenital malformations of great arteries
Primary outcomes
1
Description
Left Atrial to Aortic Ratio
Timepoint
4-5 day of life
Method of measurement
Echocardiography
2
Description
Internal Ductal Diameter
Timepoint
4-5 day of life
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administration of 15mg/kg oral acetaminophen every 6 hours for 48 hours during first 24 hours after birth