Preterm BirthNCT01753843
Brief Delay in Cord Clamping and Neurobehaviour in Preterms
A study testing early cord clamping and Brief Delay in cord clamping in people with Preterm Birth, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
RESEARCH HYPOTHESIS Brief delay(>30 sec to <60 sec ) in cord clamping as compared to early cord clamping (< 20 sec) leads to a better short term neurobehavioural outcome in preterm (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants (n.a.p.i.) at 37 weeks of post conceptional age Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- early cord clamping and Brief Delay in cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2012to Jul 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All preterm deliveries -infants born at 34 weeks 0 days to 36 weeks +6 days gestational age as estimated by last menstrual period or early ultrasound scan.
- Infants delivered vaginally or by caesarean section in cephalic presentation
- Singleton pregnancy
- Parental consent
Who cannot join
- Fetus with gross congenital anomaly
- Fetus with hydrops
- Rh negative pregnancy
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: A Randomised Controlled Trial to Evaluate the Role of Brief Delay in Cord Clamping in Preterm Neonates (34-36weeks) on Short Term Neurodevelopmental Outcome
RESEARCH HYPOTHESIS Brief delay(>30 sec to <60 sec ) in cord clamping as compared to early cord clamping (< 20 sec) leads to a better short term neurobehavioural outcome in preterm (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants (n.a.p.i.) at 37 weeks of post conceptional age
Read the detailed description
Delayed cord clamping (DCC) : Well described phenomenon in term infants .
- The optimal timing of clamping of umbilical cord in preterm infants : A subject of debate.
- Even a brief delay in cord clamping leads to an additional transfer of iron amounting to 40-50 mg/kg which may prevent iron deficiency.¹
- This low cost intervention can have significant public health importance in resource constrained settings.
- The effect of this intervention on neurobehaviour of preterm neonates has not been assessed.
- This aspect has been identified by WHO and Cochrane as a potentially researchable area
- Conditions
- Preterm Birth
- Being tested
- early cord clamping, Brief Delay in cord clamping
- Keywords
- Preterm Birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early cord clampingProcedure or surgery
early ( <20 seconds)
Brief Delay in cord clampingProcedure or surgery
delay in cord clamping 30 to 60 seconds
| Study group | Role | What they receive |
|---|---|---|
| early cord clamping | Active comparator | cord clamping within 20 sec Receives: Procedure: early cord clamping |
| brief delay in cord clamping | Experimental | cord clamping delayed by 30 to 60 seconds Receives: Procedure: Brief Delay in cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
short term neurobehavioral outcome
using N.A.P.I (neurobehavioural assessment of preterm infant)
Measured: at 37 weeks post conceptional age
Secondary outcomes (1)
measuring cord hematocrit
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DR. VIKRAM DATTA, Lady Hardinge Medical College
- Investigators
- Vikram Datta, M.D., Principal investigator, Lady Hardinge Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753843
- Sponsor's protocol ID
- Brief Delay in Cord Clamping
- Status last verified
- Jul 2013
- First submitted
- 18 Dec 2012
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Evaluate the Role of Brief Delay in Cord Clamping in Preterm Neonates (34-36weeks) on Short Term Neurodevelopmental Outcome
- ClinicalTrials.gov ID
- NCT01753843
- Acronym / sponsor ID
- Brief Delay in Cord Clamping
- Conditions
- Preterm Birth
- Keywords
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Dec 2012 (estimated)
- 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.
RESEARCH HYPOTHESIS Brief delay(>30 sec to <60 sec ) in cord clamping as compared to early cord clamping (< 20 sec) leads to a better short term neurobehavioural outcome in preterm (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants (n.a.p.i.) at 37 weeks of post conceptional age
Detailed description
Delayed cord clamping (DCC) : Well described phenomenon in term infants .
- The optimal timing of clamping of umbilical cord in preterm infants : A subject of debate.
- Even a brief delay in cord clamping leads to an additional transfer of iron amounting to 40-50 mg/kg which may prevent iron deficiency.¹
- This low cost intervention can have significant public health importance in resource constrained settings.
- The effect of this intervention on neurobehaviour of preterm neonates has not been assessed.
- This aspect has been identified by WHO and Cochrane as a potentially researchable area
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early cord clamping | Active comparator | Procedure: early cord clampingcord clamping within 20 sec |
| brief delay in cord clamping | Experimental | Procedure: Brief Delay in cord clampingcord clamping delayed by 30 to 60 seconds |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All preterm deliveries -infants born at 34 weeks 0 days to 36 weeks +6 days gestational age as estimated by last menstrual period or early ultrasound scan.
- Infants delivered vaginally or by caesarean section in cephalic presentation
- Singleton pregnancy
- Parental consent
Key exclusion criteria (3 listed)
- Fetus with gross congenital anomaly
- Fetus with hydrops
- Rh negative pregnancy
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 |
|---|---|---|
| early cord clampingearly ( <20 seconds) | Procedure or surgery | early cord clamping |
| Brief Delay in cord clampingdelay in cord clamping 30 to 60 seconds | Procedure or surgery | brief delay in cord clamping |
Primary outcome
short term neurobehavioral outcome
Time frame: at 37 weeks post conceptional age
using N.A.P.I (neurobehavioural assessment of preterm infant)
1 secondary outcome
measuring cord hematocrit
Time frame: at birth
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 8 Jul 2013.
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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.
Vikram Datta, M.D. principal investigator
Lady Hardinge Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early cord clamping and Brief Delay in cord clamping in people with Preterm Birth, 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 4 inclusion and 3 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 8 Jul 2013. 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?
short term neurobehavioral outcome (time frame: at 37 weeks post conceptional age). 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 8 Jul 2013.