| CTRI Number |
CTRI/2017/10/010012 [Registered on: 05/10/2017] Trial Registered Prospectively |
| Last Modified On: |
23/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial comparing low dose versus standard dose of intravenous paracetamol for PDA closure in very premature babies |
|
Scientific Title of Study
|
Randomized controlled trial of two different doses of intravenous paracetamol for PDA closure in preterm infants less than 30 weeks |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaibhav Jain |
| Designation |
DNB Neonatology resident (Senior resident) |
| Affiliation |
Surya Childrens Medicare Pvt Ltd |
| Address |
Department of Neonatology, 4th floor, New building,Surya Childrens Medicare Pvt Ltd.S.V. Road,Santacruz West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9406856948 |
| Fax |
|
| Email |
vaibhavjain100989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haribalakrishna Balasubramanian |
| Designation |
Consultant neonatologist (Guide) |
| Affiliation |
Surya Childrens Medicare Pvt Ltd |
| Address |
Department of Neonatology, 4th floor, New building,Surya Childrens Medicare Pvt Ltd.S.V. Road,Santacruz West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9820457078 |
| Fax |
|
| Email |
doctorhbk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Jain |
| Designation |
DNB Neonatology resident (Senior resident) |
| Affiliation |
Surya Childrens Medicare Pvt Ltd |
| Address |
Department of Neonatology, 4th floor, New building,Surya Childrens Medicare Pvt Ltd.S.V. Road,Santacruz West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9406856948 |
| Fax |
|
| Email |
vaibhavjain100989@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Surya Childrens Medicare Private limited |
| Address |
Department of neonatology, 4th floor, junction of S.V Road and Dattatray road,S.V. Road, Santacruz West, Mumbai, Maharashtra |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaibhav Jain |
Surya Childrens Hospital |
Department of Neonatogy, 4th floor, New building,Surya Childrens Medicare Pvt Ltd.S.V. Road,Santacruz West, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9406856948
vaibhavjain100989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Surya Childrens Medicare Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Premature neonates at birth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Higher dose paracetamol group |
This group will receive intravenous paracetamol in dosage of 15mg/kg/dose 4 times a day for 5 days |
| Intervention |
Lower dose paracetamol group |
This group will receive intravenous paracetamol in dosage of 10mg/kg/dose 4 times a day for 3 days |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
Preterm infants with a) gestation age less than 28weeks or b) between 28-30 weeks on invasive mechanical ventilation or on CPAP with FiO2 requirements more than 35%
AND
having 2D echocardiographic evidence of hemodynamically significant PDA (duct size more than 1.5mm narrowest internal diameter, Left Atrium/Aorta more than 1.5, left to right flow across shunt, reversal of flow in distal aorta) diagnosed at 18-24 hours of life.
|
|
| ExclusionCriteria |
| Details |
1. Infants having complex cyanotic heart disease or duct dependent cardiac lesion.
2. Infants who were admitted to hospital after 72 hours of life.
3. Infants perceived unlikely to survive the first week of life.
4. Antenatal diagnosed serious congenital anomaly such as multicystic dysplastic kidney and polycystic disease of kidney)
5. maternal tocolytic therapy with indomethacin or another prostaglandin inhibitor within 72 hrs prior to delivery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PDA closure rate in low dose and high dose paracetamol group. PDA closure is defined as absence of flow through the ductus. |
Day 6 of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All cause Mortality. |
During NICU stay |
| Duct reopening rate. |
During NICU stay |
| Requirement of multiple courses/higher doses |
During NICU stay |
| Requirement of ibuprofen/indomethacin |
During NICU stay |
| Surgical ligation rate. |
During NICU stay |
| Rate of adverse effects (increased S.creatinine {more than 1 mg%}, oliguria {urine output less than 0.5ml/kg/hr for 6 hours}, increased transaminases level {more than 2 times ULN}, thrombocytopenia {platelet count less than 100000/mm3}, gastrointestinal hemorrhage). |
end of first week of life |
| Number of days on invasive mechanical ventilation/ NIV/ oxygen therapy |
During NICU stay |
| Duration of hospital stay |
NICU stay |
| Retinopathy of prematurity requiring treatment (injection avastin or laser) |
During NICU stay |
| Bronchopulmonary dysplasia |
During NICU stay |
| Intraventricular hemorrhage (all grades and grade 3 and grade 4) |
During NICU stay |
| NEC (grade 2 and 3) |
During NICU stay |
| Periventricular leukomalacia |
During NICU stay |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2017 |
| Date of Study Completion (India) |
20/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The primary purpose of the study is to compare the efficacy of higher dose (15mg/kg/dose, 4 times a day for 5 days) versus lower dose (10mg/kg/dose 4 times a day for 3 days) of intravenous paracetamol in the closure of PDA in infants less than 30 weeks gestation and having hemodynamically significant PDA. Eligible infants will be allocated to one of the 2 groups after taking written informed consent from the parents. Daily echocardiographic examination will be performed during the intervention to look for PDA closure. This is a non inferiority trial. Estimated closure rate in higher dose paracetamol group to be 90% with accepted non inferiority margin of 20%. For power of study to be 80% with confidence interval of 95%, the sample size required in both groups is 50 (total 100).
Recruitment for the study has been completed - December 2020. The primary outcome will be assessed using an intention to treat analysis and per protocol analysis (excluding patients that did not receive the full course of the assigned intervation) |