| CTRI Number |
CTRI/2024/09/073297 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the added advantages of further delay in umbilical cord clamping in preterm neonates. |
|
Scientific Title of Study
|
Delayed cord clamping for 1 minute versus 2-3 minutes in preterm neonates, a double blinded randomised controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anitha Ananthan |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Seth GS Medical College and KEM hospital |
| Address |
NICU,ward 38, 10th floor, new building, KEM hospital, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107138 |
| Fax |
|
| Email |
ani.gem81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amruta Amte |
| Designation |
Senior Resident |
| Affiliation |
Seth GS Medical College and KEM hospital |
| Address |
NICU,ward 38, 10th floor, new building, KEM hospital, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107138 |
| Fax |
|
| Email |
amruta.amte.aa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta Amte |
| Designation |
Senior Resident |
| Affiliation |
Seth GS Medical College and KEM hospital |
| Address |
NICU,ward 38, 10th floor, new building, KEM hospital, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107138 |
| Fax |
|
| Email |
amruta.amte.aa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology,New building, 10th floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India 400012 |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neonatology
New building 10th floor
KEM Hospital, Parel, Mumbai, India, 400012
Mumbai |
| Type of Sponsor |
Government medical college |
|
|
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 Anitha Ananthan |
Seth GS Medical College and KEM Hospital |
Department of Neonatology
New building 10th floor
King Edward Memorial Hospital
Mumbai
MAHARASHTRA |
02224107035
ani.gem81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II relating to biomedical and health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All preterm newborns |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delayed umbilical cord clamping for 2-3 minutes. |
Delayed clamping of the umbilical cord for 2-3 minutes after birth in preterm neonates. |
| Comparator Agent |
Delayed umbilical cord clamping for 1 minute |
Delayed umbilical cord clamping for 1 minute after birth in preterm neonates |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
All preterm babies less than 37 weeks gestational age. |
|
| ExclusionCriteria |
| Details |
1. Non vigorous baby.
2. Prenatally diagnosed major congenital anomaly.
3. Intrauterine fetal death.
4. Hydrops.
5. In utero transfusion/laser/amnioreduction.
6. Antepartum Haemorrhage.
7. Active maternal bleeding from abruption/placental disruption at time of delivery, cord tear/avulsion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurological outcome at 1 year of age. |
12months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality |
28 days and 1 year |
| Severe intraventricular haemorrhage. |
28 days |
| Periventricular Leukomalacia |
28 days and 1 year |
| Retinopathy of prematurity. |
21 days,28 days |
| Necrotising Enterocolitis. |
28days |
| Respiratory distress syndrome |
2 days |
| Duration of mechanical ventilation in days. |
28 days |
| Bronchopulmonary dysplasia. |
28 days |
| Haemodynamically significant Patent Ductus Arteriosus requring treatment. |
7 days |
| Polycythemia |
At 6 hours, 6 weeks after birth |
| Duration of phototherapy. |
28 days |
| Number of blood transfusions required. |
28 days |
| Highest total bilirubin. |
28 days |
| Need for inotropes. |
1 day, 7 days,28 days |
| length of NICU stay |
28 days |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Delayed cord clamping (DCC)which is umbilical cord clamping done after 30-60 seconds of birth is currently practised as a standard of care in all term infants and stable preterm infants. In term infants, DCC increases haemoglobin levels and improve iron stores in the first several months of life. In preterm infants, DCC improves transitional circulation, increases red blood cell volume, decreases the need for blood transfusion, lowers necrotizing enterocolitis and intraventricular haemorrhage. However, the optimal timing of umbilical cord clamping in preterm infants is unclear. There is a concern of DCC causing polycythemia and neonatal jaundice in preterm infants. A brief delay in cord clamping in preterm infants has shown to stabilize circulation, decreases fluid bolus and inotropic requirement as well. DCC has shown to improve long term neurological and developmental outcomes. Various guidelines recommend DCC for more than 30 seconds, 30 to 60 sec, atleast 60 seconds, 30 to 180 minutes in stable preterm infants. A recent network meta-analysis has compared different timings of DCC in preterm infants and have emphasised the need for prolonged DCC. They have recommended further trials to confirm the benefits. Given that DCC is beneficial for over all outcomes in preterm infants and there is no study till date comparing 1 min vs 2 to 3 minute DCC, we aimed to compare the same. The primary outcome will be abnormal neurodevelopmental outcome at 1 year of age. Other outcomes such as mortality, IVH, PVL, NEC, ROP, duration of mechanical ventilation, phototherapy, need for inotropes, PDA, NICU stay duration, sepsis, BPD, hematocrit at 6 hours and 6 weeks will be studied. |