| CTRI Number |
CTRI/2024/05/067918 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of the iron status and cardiopulmonary stabilisation for the first 10 minutes after birth with two different techniques of DCC i.e. cord clamping at 1 minute and after placental delivery among late preterm infants not requiring resuscitation |
|
Scientific Title of Study
|
Physiological versus one minute based delayed cord clamping among late preterm infants not requiring resuscitation a 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 Neeraj Gupta |
| Designation |
PROFESSOR, DEPARTMENT OF NEONATOLOGY |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Neonatology, 3rd floor, Academic block, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
80039996908 |
| Fax |
|
| Email |
neerajpgi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Gupta |
| Designation |
Professor, Department of Neonatology |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Neonatology, 3rd floor, Academic block, All India Institute of Medical Sciences Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
80039996908 |
| Fax |
|
| Email |
neerajpgi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Krishna Kumar |
| Designation |
DM resident, Department of Neonatology |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Neonatology, All India Institute of Medical Sciences Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7978754878 |
| Fax |
|
| Email |
kkrishnakmkcg@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Rajasthan, India, 342005 |
|
|
Primary Sponsor
|
| Name |
Government medical college authority |
| Address |
All India Institute of Medical Sciences, Jodhpur, Rajasthan, India, 342005 |
| 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 Neeraj Gupta |
AIIMS Jodhpur |
Department of Neonatology and Department of Obstetrics and Gynaecology
Jodhpur
RAJASTHAN |
8003996908
neerajpgi@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,All India Institute Of Medical Sciences Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Late preterm Infants, born at AIIMS Jodhpur |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed cord clamping after 1 minute |
This study is aimed at the evaluation of the iron status as a primary outcome and cardiopulmonary stabilisation in terms of SpO2 and heart rate for the first 10 minutes after birth with two different techniques of DCC i.e. cord clamping at 1 minute and after placental delivery |
| Intervention |
Physiological based cord clamping that is cord clamping after separation of placenta |
This study is aimed at the evaluation of the iron status as a primary outcome and cardiopulmonary stabilisation in terms of SpO2 and heart rate for the first 10 minutes after birth with two different techniques of DCC i.e. cord clamping at 1 minute and after placental delivery |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Month(s) |
| Gender |
Both |
| Details |
1. Late preterm (34+0 - 36+6 weeks) singleton pregnancy with anticipated delivery (gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available)
2. Parents residing within 100 kilometers of Jodhpur & consenting to follow up till first 6-8 weeks of age |
|
| ExclusionCriteria |
| Details |
1. Cesarean section under general anesthesia (GA) due to any reason (contra-indication or procedure failure or failure of effect of spinal anesthesia)
2. Multiple gestation
3. Psychiatric illness or maternal drugs which may interfere or prohibits breastfeeding
4. Mothers with HIV or AIDS
5. Rh iso-immunized pregnancy with evidence of hydrops fetalis
6. Non-immune hydrops fetalis
7. Any suspected or confirmed congenital anomaly or syndrome in the fetus
8. Chorioamnionitis or any systemic infection in last one week before delivery
9. Severe fetal growth restriction (fetal weight less than 3rd centile for that gestational age) or AEDF or REDF (absent end diastolic flow or reversed end diastolic flow |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome:
1. Serum ferritin levels at 6-8 weeks of age |
six to eight weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neonatal
I. To compare birth weight
II. To compare APGAR score at 1, 5 and 10 minutes of life
III. To compare modified APGAR score at 5 and 10 minutes
IV. To compare PCV at about 12 hours of age
V. To compare the incidence of significant hyperbilirubinemia (jaundice requiring phototherapy and/or exchange transfusion as per American Academy of Pediatrics [AAP] charts) till discharge |
six to eight weeks |
VI. To compare incidence of respiratory support requirement due to any cause till discharge
VII. To compare NICU admission till discharge
VIII. To compare hemoglobin, incidence of iron deficiency and iron deficiency anemia at 14 (+4) weeks of age
IX. To compare incidence of exclusive breastfeeding rate at 14 weeks of age
X. To compare anthropometry (weight, length and head circumference) till 14 (+4) weeks of age
XI. To compare incidence of hospitalization till 14 (+4) weeks of age
XII. To compare morbidities (diarrhea, pneumonia, seizures) till 14 weeks of age |
six to eight weeks |
} Maternal
I. To compare incidence of PPH
II. To compare need for therapeutic uterotonics or surgical management or manual removal of placenta for PPH
III. To compare need of blood transfusion
IV. To compare ICU admission
V. To compare all cause in-hospital maternal mortality till discharge
VI. To compare fall in maternal haemoglobin 24 (4) hours after delivery |
six to eight weeks |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
07/06/2024 |
| 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="1"
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) is the standard of care among healthy infants after birth due to various benefits. Ideal timing of DCC is not known and varies from 30-60 seconds (AAP) till placental delivery. We hypothesise that this timing of clamping the cord should be left upon the mother-infant dyad and should not be time-based. This is because the placental transfusion takes place till the placenta separates. Therefore, the ideal time of DCC possibly would be clamping the cord once the placenta separates (physiological based cord clamping [PBCC]). However, there is paucity of data on neonatal outcome in delayed versus physiological based cord clamping (defined as clamping after separation of placenta) in healthy late preterm infants. Population: Late preterm (34+0-36+6)) infants not requiring resuscitation Intervention: Clamping the cord after separation of the placenta (cesarean section: placental separation is noted by gush of the blood and placenta coming out of the incision; vaginal delivery: placental separation is noted when the placenta has descended into the vagina with gush of blood and lengthening of the cord) Control: Clamping cord at 60 seconds Outcomes: Serum ferritin level at 6-8 weeks
Reaearch question: Does physiological-based cord clamping (PBCC; clamping the cord after separation of placenta) (I) among late preterm infants (34+0-36+6 weeks) not requiring resuscitation (P) improves serum ferritin levels at 6-8 weeks (O) as compared to one-minute based delayed cord clamping (C) |