Purpose: efficacy assessment of preventive paracetamol dosage for the closure of patent ductus arteriosus (PDA) in preterm infants.
Design: The study is a randomized double-blind clinical trial which will perform on 160 preterm neonates with less than 34 weeks gestational age in NICU ward. Neonates randomly divided into the test and control groups.
Method: Neonates in test group, will receive intravenous paracetamol with the loading dose of 20 mg/kg and maintenance dose of 7.5 mg/kg every 6 hours during first three postnatal days and the neonates in control group will not receive any drugs.
Study participants: all of preterm neonates which will hospitalize between November 2015 and November 2016 in in NICU ward of Afzalipour hospital of Kerman city, Iran.
Intervention: intravenous paracetamol with the loading dose of 20 mg/kg and maintenance dose of 7.5 mg/kg every 6 hours during first three postnatal days
Outcome: frequency of closing in patent ductus arteriosus after study intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012718994N2
Registration date:2017-03-08, 1395/12/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-08, 1395/12/18
Registrant information
Name
Amir Bahrami-Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2682
Email address
bahrami.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-06-22, 1395/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assess the efficacy of preventive paracetamol dosage for the closure of patent ductus arteriosus (PDA) in preterm infants.
Public title
Assess the efficacy of paracetamol for the closure of patent ductus arteriosus (PDA) in preterm infants.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Less than 32 week gestational age
Exclusion Criteria: Pulmonary artery atresia; aorta coarctation; major maternal anomalies; Hydrops fetalis; pulmonary hypertension; mortality of infants during prophylactic therapy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization in this study will perform by Balance-Block randomization method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research of Kerman university of medical sciences
Street address
Ebnesina Street- Jahad Blv-Tahmasb Abad
City
Kerman
Postal code
Approval date
2017-02-13, 1395/11/25
Ethics committee reference number
IR.KMU.REC.1395.841
Health conditions studied
1
Description of health condition studied
Patent ductus arteriosus (PDA)
ICD-10 code
Q 25.0
ICD-10 code description
Persistent ductus arteriosus
Primary outcomes
1
Description
Ventilator usage time
Timepoint
Three days after Intervention
Method of measurement
according NICU report
2
Description
Hospitalization time
Timepoint
Three days after Intervention
Method of measurement
according NICU report
3
Description
Mortality rate of infants
Timepoint
Three days after Intervention
Method of measurement
according NICU report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: more than routine NICU management, Paracetamol with initial dosage 20 mg/kg and maintenance dosage: 7.5 mg/kg/dose every six hours for three days.