| CTRI Number |
CTRI/2022/02/040396 [Registered on: 17/02/2022] Trial Registered Prospectively |
| Last Modified On: |
09/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Birth vitamin K in preterm babies – A comparison of three regimens |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED TRIAL COMPARING VITAMIN K STATUS IN
LESS THAN 32WEEKS AND OR LESS THAN 1500GMS AFTER 3 PROPHYLACTIC DOSAGE REGIMENS (0.3
VS 0.5 MG VS 1MG IM) AT BIRTH |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Usha Devi R |
| Designation |
Associate Professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Neonatal intensive care unit, B block, Chettinad Hospital and Research Institute,
SH 49A, Rajiv Gandhi Salai (OMR), Kelambakkam, Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9962653294 |
| Fax |
|
| Email |
dr.ushaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Giridhar S |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Neonatal intensive care unit, B block, Chettinad Hospital and Research Institute,
SH 49A, Rajiv Gandhi Salai (OMR), Kelambakkam, Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841027228 |
| Fax |
|
| Email |
giridharsethu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Giridhar S |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Neonatal intensive care unit, B block, Chettinad Hospital and Research Institute,
SH 49A, Rajiv Gandhi Salai (OMR), Kelambakkam, Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841027228 |
| Fax |
|
| Email |
giridharsethu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute,
SH 49A, Rajiv Gandhi Salai (OMR), Kelambakkam, Chengalpattu, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Giridhar |
Chettinad Hospital and Research Institute |
Neonatal intensive care unit, B block, Chettinad Hospital and Research Institute,
SH 49A, Rajiv Gandhi Salai (OMR), Kelambakkam, Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU |
9841027228
giridharsethu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P53||Hemorrhagic disease of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.3 mg intramuscular vitamin K |
0.3 mg intramuscular vitamin K is given within 1 hour of admission in the NICU |
| Comparator Agent |
0.5 mg intramuscular vitamin K |
0.5 mg intramuscular vitamin K is given within 1 hour of admission in the NICU |
| Intervention |
1 mg intramuscular vitamin K |
1 mg intramuscular vitamin K is given within 1 hour of admission in the NICU |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm neonates less than 32 weeks of gestation and/or less than 1500 g born during the study period |
|
| ExclusionCriteria |
| Details |
Outborn neonates who already received vitamin K, those with antenatally diagnosed major congenital malformations and intracranial hemorrhage, neonates whose mothers had thrombophilia or platelet disorders, and who received drug treatment with known vitamin K antagonists. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of PIVKA-II levels among study groups on day 5 of life. |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of PIVKA-II levels on day 28 of life, 2. Proportion of
vitamin K sufficient infants on days 5 and 28. 3. Clinical morbidities: Cranial ultrasound abnormalities,
peak bilirubin levels and duration of phototherapy, pulmonary haemorrhage, necrotizing enterocolitis (NEC), and mortality |
Day 5, Day 28, Time of admission till discharge |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet- Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Informed written consent will be obtained beforehand, in case of an anticipated preterm delivery or after delivery in unanticipated cases. The random sequence of varying block sizes will be generated online and serially-numbered opaque sealed envelopes will be prepared. The enrolled infants will be then randomly allocated to receive 1 of 3 regimens of vitamin K after admission to the neonatal intensive care unit (0.3 mg IM, 0.5 mg IM, and 1 mg IM). The intervention is unblinded but the lab technician who process the blood samples and the radiologist who does the scans will not be aware of the allocation. The vitamin K preparation used will contain Phytomenadione (1.0 mg/0.5mL). As per the instructions of the investigator, the staff nurse, will prepare the drug and administer it to the infant using a 1 ml syringe along with a 26 G needle on the anterolateral aspect of the right thigh (left thigh if contraindicated on right for any reason), within 1 hour of admission in the NICU. Protein induced in vitamin K absence II (PIVKA-II), a sensitive biomarker of vitamin K deficiency, will be estimated in cord blood and on study days 5 and 28, by using Elecsys® PIVKA-II enzyme-linked immune sorbent assay (ELISA) based on double antibody sandwich technology. PIVKA-II > 0.028 AU/ml is considered vitamin K deficient. Cranial ultrasonography (CUSG) will be routinely done in enrolled infants on days 1, 3, and 7, if birth weight < 1000 g and on days 3 and 7 if weight > 1000 g, or anytime as decided by the treating doctor. Any infant showing abnormal findings in the initial scans will be followed up by a weekly ultrasound. The CUSG grading for PIVH (Periventricular/Intraventricular hemorrhage) will be done according to Papile’s classification. During the entire study period, all the participants will be closely monitored for any bleeding and if detected, additional PIVKA-II levels with routine coagulation profile will be measured, to determine if the bleeding was due to VKDB and a single dose of 0.2mg IM of vitamin K will be immediately administered. |