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CTRI Number  CTRI/2024/02/063323 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 24/02/2024
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   Effects of naval cord squeezing in small babies not breathing at birth  
Scientific Title of Study   Hemodynamic Effects of Umbilical Cord Milking versus Early Cord Clamping in Non-vigorous Intrauterine Growth Restricted Neonates: A Randomized 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  Poonam Singh  
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Room no 016120, Block A, Medical College Building, Department of Neonatology, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8527106059  
Fax    
Email  drpoonamujn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrBhagayshree P R 
Designation  Academic Senior Resident (DM Neonatology)  
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Room No 016121, Block A, Medical College Building, Department of Neonatology, All Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8527106059  
Fax    
Email  bhagyashree.pr41@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Poonam Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Room no 016120, Block A, Medical College Building, Department of Neonatology, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8527106059  
Fax    
Email  drpoonamujn@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Rishikesh  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rishikesh  
Address  All India Institute of Medical Sciences, Rishikesh Virbhadra Road, Pashulok, District - Dehradun Uttarachal - 249203  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poonam Singh  All India Institute of Medical Sciences, Rishikesh  All India Institute of Medical Sciences, Rishikesh, Virbhadra Road, Pashulok, District-Dehradun, Uttaranchal, 249203
Dehradun
UTTARANCHAL 
8527106059

drpoonamujn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P059||Newborn affected by slow intrauterine growth, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Early cord clamping  After delivery, cord clamping will be done within 30 seconds  
Intervention  Umbilical cord milking   After complete delivery, the uncut umbilical cord will be grasped gently. Approximately 20 cm of the cord will be squeezed at a speed of 10cm/sec towards the infant for four times. A short waiting time of 2 seconds in between two squeezing movements will be ensured for quick refilling the cord.  
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  0.50 Day(s)
Gender  Both 
Details  Antenatally detected intrauterine growth restricted neonates more than 28-weeks gestation who are non-vigorus at birth. 
 
ExclusionCriteria 
Details  1. Neonates born to mother with
a. Hemodynamic instability
b. Placental previa/abruption
c. Postpartum hemorrhage
d. Multiple gestation: Monochorionic twins.
e. Rh sensitized pregnancy
2. Major congenital malformation
3. Fetal hydrops
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Left ventricular output (mL/kg/min) by bedside echocardiography   At 24 ± 2 hours of life 
 
Secondary Outcome  
Outcome  TimePoints 
1. Left atrial to aortic root ratio
2. Left ventricle dimensions for fractional shortening
3. Right ventricular output
4. Tricuspid annular plane systolic excursion
5. Peak velocities of the E wave and A wave and E by A ratio
6. E wave deceleration time
7. Isovolumic relaxation time
8. Superior vena cava blood flow
9. Patent ductus arteriosus, patent foramen ovale
10. Pulmonary arterial pressure by tricuspid regurgitant jet if present
11. Mean blood pressures
12. Venous hematocrit
13. Incidence of significant neonatal hyperbilirubinemia and duration of phototherapy during hospital stay
14. Incidences of polycythemia, intraventricular hemorrhage, respiratory distress requiring respiratory support, feeding intolerance and necritizing enetrocolitis (Modified Bell Stage II and beyond) during hospital stay
15. Final outcome
16. Duration of hospital stay
 
At 24 ± 2 hours of life 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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 4 
Date of First Enrollment (India)   05/03/2024 
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 Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bhagyashree.pr41@gmail.com].

  6. For how long will this data be available start date provided 01-03-2027 and end date provided 01-03-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Aim: To evaluate the effects of umbilical cord milking (UCM) compared to early cord clamping (ECC) on hemodynamic parameters in intrauterine growth restricted neonates requiring resuscitation.

Population: Antenatally detected IUGR neonates > 28-weeks gestation who are non-vigorus (defined as per NRP AAP) at birth.

IUGR - Defined as fetal weight in serial ultrasonography below the 10th percentile for the gestation as per INTERGROWTH 21st standard.

Intervention: NICU and delivery unit team would be trained in the study procedure before the trial is started. In all cases after birth, the neonates will be placed on the mother’s abdomen in case of vaginal delivery and on the thighs in case of Caesarean delivery before clamping the cord. The intervention in the UCM group will include gentle grasping of the uncut umbilical cord and squeezing approximately 20 cm of the cord at the speed of 10cm/sec towards the infant for four times. A short waiting time of 2 seconds in between two squeezing movements will be ensured for quick refilling the cord.

In ECC group, the delivering obstetrician will place the baby on the mother as previously described and clamp the umbilical cord within 30 seconds and attending Neonatologist will transfer the neonate under radiant warmer. Neonatal care would be provided according to standard practice at the hospital.

Sample size: In a study comparing UCM with ECC in non-vigorous late preterm and term neonates, mean ± SD left ventricular output was 225 ± 64 vs 187± 52 mL/kg/min, respectively. Expecting a similar difference in primary outcome, considering power of the study as 80% and 2 tailed alpha error as 0.05, a total sample size of 74 was calculated (37 in each group)

Statistical methods: All the data will be uploaded into the excel sheet (Microsoft excel 2016). IBM SPSS version 21.0 to be used for data analysis. Analysis of data will be done by using SPSS software version 21. Continuous variables with normal distribution will be presented as mean ± SD. Categorical variables will be presented as proportions. Quantitative data with normal distribution will be compared using Student T test and those with skewed distribution will be analyzed using Mann Whitney U test. Data expressed as proportions will be compared using Chi square or Fisher exact test as applicable. Mean and 95% confidence interval will be calculated for outcome variables. Subgroup analysis will be done as per stratifications with analysis of variance (ANOVA) test. A p-value of <0.05 will be considered statistically significant.

 
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