| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhagyashree.pr41@gmail.com].
- 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.
- 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. |