| CTRI Number |
CTRI/2025/09/094161 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
“Resuscitation of Newborns with Cord Left Intact versus Conventional Cord Clamping” |
|
Scientific Title of Study
|
“Efficacy and safety of resuscitation in neonates with an intact umbilical cord until placental delivery versus conventional cord clamping: 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 |
Dr Dinesh Munian |
| Designation |
Associate Professor |
| Affiliation |
Medical College and Hospital, Kolkata |
| Address |
SNCU NICU Complex, Department of Paediatrics and Neonatology, Medical College and Hospital, Kolkata, 88, College Street, Kolkata 700073
Kolkata
WEST BENGAL
700073
India |
| Phone |
9163288916 |
| Fax |
|
| Email |
dr.dineshmunian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Munian |
| Designation |
Associate Professor |
| Affiliation |
Medical College and Hospital, Kolkata |
| Address |
SNCU NICU Complex, Department of Paediatrics and Neonatology, Medical College and Hospital, Kolkata, 88, College Street, Kolkata 700073
Kolkata
WEST BENGAL
700073
India |
| Phone |
9163288916 |
| Fax |
|
| Email |
dr.dineshmunian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourav Nandi |
| Designation |
Post Graduate Trainee |
| Affiliation |
Medical College and Hospital, Kolkata |
| Address |
SNCU NICU Complex, Department of Paediatrics and Neonatology, Medical College and Hospital, Kolkata, 88, College Street, Kolkata 700073
Kolkata
WEST BENGAL
700073
India |
| Phone |
9339112454 |
| Fax |
|
| Email |
souravnandi.2016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Medical College and Hospital, Kolkata, 88, College Street, Kolkata 700073, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
SNCU and NICU Complex Department of Pediatrics Medical College and Hospital Kolkata |
| Address |
Medical College and Hospital, Kolkata, 88, College Street, Kolkata 700073, West Bengal, Kolkata |
| 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 Dinesh Munian |
Medical College and Hospital, Kolkata |
Department of Neonatology, SNCU NICU Complex and Labour room OT Complex, Eden Building, Medical College and Hospital, Kolkata, 88, College Street, kolkata 700073, West Bengal
Kolkata
WEST BENGAL |
9163288916
dr.dineshmunian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH, MEDICAL COLLEGE, KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O76||Abnormality in fetal heart rate and rhythm complicating labor and delivery, (2) ICD-10 Condition: O68||Labor and delivery complicated byabnormality of fetal acid-base balance, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL CORD CLAMPING |
In this group, newborns requiring resuscitation will undergo conventional cord clamping. After clamping, the newborn will be transferred to a radiant warmer for resuscitation. Standard resuscitation measures, following the Neonatal Resuscitation Program (NRP) guidelines, will be performed, including stimulation, airway positioning, suction if required, positive pressure ventilation, and escalation as needed. This reflects the routine standard practice of newborn resuscitation following cord clamping.
|
| Intervention |
INTACT CORD RESUSCITATION TILL PLACENTAL DELIVERY |
In this group, newborns who require resuscitation at birth will be managed while the umbilical cord remains intact and attached to the placenta. The cord will not be clamped or cut until the placenta is delivered. Resuscitation will be initiated at the mother’s bedside using a mobile resuscitation trolley or platform. Standard steps of neonatal resuscitation, as per the Neonatal Resuscitation Program (NRP) guidelines, including stimulation, airway positioning, suction if required, provision of positive pressure ventilation, and further steps as clinically indicated, will be provided with the cord still intact. This approach allows for continued placental transfusion during resuscitation, which may provide hemodynamic and oxygenation benefits. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
Neonates will be eligible for inclusion in the study if all of the following criteria are met. The gestational age must be more than 34 weeks, including late preterm and term neonates, confirmed by early ultrasound or last menstrual period with clinical correlation. The place of birth must be the study center, either by vaginal or cesarean delivery. Eligible neonates must be identified antenatally or intrapartum as being at risk for requiring resuscitation at birth, based on clinical indicators. These include abnormal or non-reassuring fetal heart rate patterns as defined by ACOG Category two or three, or suspicious or pathological CTG as per NICE 2014 criteria; labor or delivery complications such as shoulder dystocia, fetal macrosomia, obstructed labor, assisted vaginal delivery, malpresentation or malposition; amniotic fluid or placental issues like meconium-stained fluid, polyhydramnios, oligohydramnios, chorioamnionitis, or intrapartum bleeding; maternal medical or obstetric conditions including chronic hypertension, preeclampsia, eclampsia, severe maternal anemia at delivery, and twin pregnancy where only the second twin in diamniotic-dichorionic gestations is eligible for randomization; and fetal growth issues such as antenatally diagnosed fetal growth restriction. In addition, neonates must require resuscitation at birth, defined as not crying or having inadequate respiratory effort within the first 30 seconds of life, as determined by the neonatal team. Only live-born infants with a detectable heart rate at birth will be included. Both singleton pregnancies and the second twin in diamniotic dichorionic twins are eligible. Written informed consent from parents or legal guardians is mandatory, either obtained antenatally in identified high risk cases or postnatally through deferred consent where prior consent is not feasible, in accordance with ethical approval. |
|
| ExclusionCriteria |
| Details |
Neonates will be excluded from the study if any of the following criteria are present. These include gestational age less than 34 weeks, stillbirth, or absence of a detectable heart rate at birth. Multiple gestations will be excluded except for the second twin in diamniotic dichorionic twin pregnancies; monoamniotic, monochorionic twins, or higher order multiples are ineligible. Congenital or antenatal fetal conditions that preclude inclusion include antenatally diagnosed life threatening anomalies such as severe hydrops fetalis, lethal chromosomal abnormalities, major malformations incompatible with life, suspected or confirmed severe fetal anemia, and a bad obstetric history as per RCOG guidelines, including three or more consecutive spontaneous miscarriages, previous unexplained intrauterine fetal deaths, or prior neonatal deaths of unclear cause. Maternal and obstetric exclusions include complete placental abruption, placenta previa with hemorrhagic risk, severe maternal anemia needing urgent delivery intervention, symptomatic chorioamnionitis with maternal or fetal instability, symptomatic COVID 19 infection requiring oxygen or ICU care, intrapartum bleeding requiring urgent intervention, maternal seropositivity for HIV, hepatitis B or C, and use of assisted reproductive technologies like IVF due to altered placental or neonatal physiology. Delivery related exclusions comprise any short or compromised umbilical cord scenario such as cord prolapse, avulsion, knot, or very short cord that impedes safe bedside resuscitation, as well as instrumental delivery resulting in neonatal head trauma that precludes intact cord handling. Cases where comfort care is the planned approach or anticipated neonatal demise is expected are also excluded. Finally, parental refusal to consent or any concern raised by the attending obstetrician or neonatologist regarding safety or appropriateness of the intervention at the time of delivery will result in exclusion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of the composite outcome of neonatal mortality or moderate-to-severe hypoxic-ischemic encephalopathy, defined according to Sarnat and Sarnat staging, between neonates undergoing resuscitation with the umbilical cord left intact until placental delivery and those receiving resuscitation after conventional cord clamping. |
Within the first seven days of life. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="580"
Sample Size from India="580"
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)
|
13/09/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the safety and efficacy of intact cord resuscitation until placental delivery compared to conventional cord clamping in neonates born at or beyond 34 weeks of gestation who require resuscitation at birth. While delayed cord clamping is standard for vigorous neonates, those needing resuscitation often undergo immediate cord clamping and may miss the benefits of continued placental transfusion. Emerging evidence suggests that initiating resuscitation with an intact cord may improve cardiovascular stability and oxygenation. However, most existing studies have assessed only short durations of intact cord resuscitation and have not extended it until complete placental expulsion. This trial will assess whether prolonged intact cord resuscitation improves critical neonatal outcomes, including mortality and moderate to severe hypoxic-ischemic encephalopathy within the first seven days of life. Secondary objectives include evaluating detailed neonatal clinical and hematological outcomes, maternal safety parameters, and the practical feasibility of implementing intact cord resuscitation in a real-world clinical setting. The study is designed as a prospective, open-label, parallel-group interventional trial and will generate evidence that could inform changes in neonatal resuscitation protocols, particularly in low-resource settings.
|