Hypoxic-Ischemic EncephalopathyNCT06090968
Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation
A study testing Umbilical cord milking and Immediate cord clamping in people with Hypoxic-Ischemic Encephalopathy and Perinatal Asphyxia, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to Immediate cord clamping. Read more about this study
- Who is it for?
- Ages 37 to 41 weeks
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia
- What is being tested?
- Umbilical cord milking and Immediate cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 5 Feb 2022to 4 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 41 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Vaginally born, Singleton Term gestation (≥ 37 and \& < 42 weeks), requiring resuscitation at birth
Who cannot join
- Major congenital anomaly (antenatally diagnosed or visible at birth)
- Rh negative pregnancy
- Hydrops
- Abruptio Placneta/ Placenta previa
- Fetus with absent and reversal of End Diastolic flow
- Cord avulsion
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
India1 site
Lady Hardinge Medical college
New Delhi, National Capital Territory of Delhi, 110001
About this study
Official title: Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation - A RANDOMIZED CONTROL TRIAL
The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to Immediate cord clamping.
Read the detailed description
Enrolled participants will be randomly allocated to one of two study groups: 1) Umbilical cord clamping, 2) Immediate cord clamping
Umbilical cord clamping group: In the babies requiring resuscitation during vaginal delivery, the delivering obstetrician will place the infant on the mother's abdomen and about 20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times by the obstetrical provider or by a second team member at the rate of 20 cm/2 sec. This procedure can be done in 15-20 seconds. Length of 20 cm can be estimated by the length of a sponge holding forceps which is approximately 25 cm. The umbilical cord will then clamped 2 -3 cm from the umbilical stump.
Immediate cord clamping: This will occur by clamping the umbilical cord as soon as possible (average 30 seconds).
Further resuscitation will be done in accordance with NRP 2015 guidelines. Stop watch will be used to calculate the duration after which the cord is clamped and cut, time to first breath, and time required to achieve HR > 100/min
- Being tested
- Umbilical cord milking, Immediate cord clamping
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord milkingProcedure or surgery
20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times. The entire procedure can be done in 15-20 seconds
Immediate cord clampingProcedure or surgery
clamping the umbilical cord as soon as possible (average 30 seconds)
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord milking | Experimental | 20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times. The entire procedure can be done in 15-20 seconds Receives: Procedure: Umbilical cord milking |
| Immediate cord clamping | Active comparator | clamping the umbilical cord as soon as possible (average 30 seconds) Receives: Procedure: Immediate cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypoxic Ischemic Encephalopathy
any stage as per Sarnat and Sarnat Staging
Measured: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Secondary outcomes (10)
Proportion requiring NICU admission
NICU admission due to any reason
Measured: Till 1 week of life
Level of hypoxic ischemic encephalopathy ( mild, moderate or severe)
Level of hypoxic ischemic encephalopathy as per Sarnat and Sarnat Staging
Measured: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Received blood products or saline bolus or inotropes to support blood pressure
Hypotension requiring blood products or saline bolus or inotropes
Measured: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Length of hospital stay
Duration of stay in days
Measured: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Mean Blood Pressure at 2,6,12,24,48,72 hrs
Mean Blood Pressure as assessed by non-invasive oscillometric method
Measured: From date of birth until date of death from any cause whichever come first assessed till 72 hours of life
Hyperbilirubinemia requiring phototherapy
As per AAP charts
Measured: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Proportion of neonates having APGAR score < 4 at 5 minutes of life
APGAR score (Min zero maximum Ten) assessed at 1,5 minutes (Low APGAR is bad prognosis and High APGAR is good prognosis)
Measured: Till 5 minutes of life
Neonates requiring Initial steps of resuscitation, Bag and Mask Ventilation, Intubation, chest compression and administration of drugs during resuscitation.
As per NRP 2015 guidelines
Measured: Till 1 minutes of life
Proportion of neonates developing polycythemia
Polycythemia is defined as venous hematocrit >65%
Measured: Till first 72 hours
Proportion of mortality due to any cause
Including early and late neonatal deaths
Measured: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start5 Feb 2022
- Primary completion4 Feb 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sushma Nangia, M.D., Lady Hardinge Medical College
- Investigators
- Sushma Nangia, DM (Neo), Study chair, Lady Hardinge Medical College, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090968
- Sponsor's protocol ID
- LHMC/IEC/071/UCM
- Status last verified
- Jul 2024
- First submitted
- 13 Oct 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation - A RANDOMIZED CONTROL TRIAL
- ClinicalTrials.gov ID
- NCT06090968
- Acronym / sponsor ID
- LHMC/IEC/071/UCM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 4 Feb 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to Immediate cord clamping.
Detailed description
Enrolled participants will be randomly allocated to one of two study groups: 1) Umbilical cord clamping, 2) Immediate cord clamping
Umbilical cord clamping group: In the babies requiring resuscitation during vaginal delivery, the delivering obstetrician will place the infant on the mother's abdomen and about 20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times by the obstetrical provider or by a second team member at the rate of 20 cm/2 sec. This procedure can be done in 15-20 seconds. Length of 20 cm can be estimated by the length of a sponge holding forceps which is approximately 25 cm. The umbilical cord will then clamped 2 -3 cm from the umbilical stump.
Immediate cord clamping: This will occur by clamping the umbilical cord as soon as possible (average 30 seconds).
Further resuscitation will be done in accordance with NRP 2015 guidelines. Stop watch will be used to calculate the duration after which the cord is clamped and cut, time to first breath, and time required to achieve HR > 100/min
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord milking | Experimental | Procedure: Umbilical cord milking20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times. The entire procedure can be done in 15-20 seconds |
| Immediate cord clamping | Active comparator | Procedure: Immediate cord clampingclamping the umbilical cord as soon as possible (average 30 seconds) |
Who may qualify
- Ages
- 37 to 41 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Vaginally born, Singleton Term gestation (≥ 37 and \& < 42 weeks), requiring resuscitation at birth
Key exclusion criteria (7 listed)
- Major congenital anomaly (antenatally diagnosed or visible at birth)
- Rh negative pregnancy
- Hydrops
- Abruptio Placneta/ Placenta previa
- Fetus with absent and reversal of End Diastolic flow
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord milking20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times. The entire procedure can be done in 15-20 seconds | Procedure or surgery | Umbilical cord milking |
| Immediate cord clampingclamping the umbilical cord as soon as possible (average 30 seconds) | Procedure or surgery | Immediate cord clamping |
Primary outcome
Incidence of Hypoxic Ischemic Encephalopathy
Time frame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
any stage as per Sarnat and Sarnat Staging
10 secondary outcomes
Proportion requiring NICU admission
Time frame: Till 1 week of life
Level of hypoxic ischemic encephalopathy ( mild, moderate or severe)
Time frame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Received blood products or saline bolus or inotropes to support blood pressure
Time frame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Length of hospital stay
Time frame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Mean Blood Pressure at 2,6,12,24,48,72 hrs
Time frame: From date of birth until date of death from any cause whichever come first assessed till 72 hours of life
Hyperbilirubinemia requiring phototherapy
Time frame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Proportion of neonates having APGAR score < 4 at 5 minutes of life
Time frame: Till 5 minutes of life
Neonates requiring Initial steps of resuscitation, Bag and Mask Ventilation, Intubation, chest compression and administration of drugs during resuscitation.
Time frame: Till 1 minutes of life
Proportion of neonates developing polycythemia
Time frame: Till first 72 hours
Proportion of mortality due to any cause
Time frame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sushma Nangia, DM (Neo) study chair
Lady Hardinge Medical College, New Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord milking and Immediate cord clamping in people with Hypoxic-Ischemic Encephalopathy and Perinatal Asphyxia, run by Lady Hardinge Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hypoxic Ischemic Encephalopathy (time frame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.