Neonatal DisorderNepCordIIINCT02727517
Early or Late Cord Clamping in the Depressed Neonate
A study testing Early (≤ 60 seconds) cord clamping and Delayed (≥ 180 seconds) cord clamping in people with Neonatal Disorder and Asphyxia Neonatorum, run by Uppsala University at 1 site in Nepal.
Trial summary
This study evaluates the hypothesis that delayed compared to early umbilical cord clamping will improve neonatal transition in terms of circulation and breathing during resuscitation. Read more about this study
- Who is it for?
- Ages 33 to 42 weeks
- Conditions the study is for
- Neonatal Disorder, Asphyxia Neonatorum
- What is being tested?
- Early (≤ 60 seconds) cord clamping and Delayed (≥ 180 seconds) cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNepal
- Study dates
- Apr 2016to Sep 2016
- 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 33 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn in need of resuscitation measures (no or irregular breathing despite thorough drying and additional stimulation within one minute after birth)
- Gestational age ≥ 33 weeks
Who cannot join
- Monochorionic twins (from an ultrasound scan) or clinical evidence of twin-twin transfusion syndrome, triplets or higher order multiple pregnancy, and fetuses with known congenital malformation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early or Late Cord Clamping in the Depressed Neonate - a Randomized Controlled Study in a Low-income Facility Setting for Improved Early Neonatal Outcome
This study evaluates the hypothesis that delayed compared to early umbilical cord clamping will improve neonatal transition in terms of circulation and breathing during resuscitation.
Read the detailed description
At the time of birth, the infant is still attached to the placenta via the umbilical cord. The infant is usually separated from the placenta by clamping the cord with two clamps. Early cord clamping has been generally advised to be carried out in the first 30 seconds after birth, regardless of whether the cord pulsation has ceased. However, arguments against early cord clamping include the reduction in the amount of placental transfusion and any associated benefits of extra blood volume, as delayed clamping allows time for a transfer of the fetal blood in the placenta to the infant at the time of birth.
The study will evaluate the effect of early versus delayed cord clamping in a low-income setting in children that do not spontaneously start to breathe. The randomized controlled trial will be carried out at Paropakar Maternity and Women's Hospital (PMWH) in Kathmandu.
The trial will fill several important gaps in relation to early and delayed cord clamping and results.
- Conditions
- Neonatal Disorder, Asphyxia Neonatorum
- Being tested
- Early (≤ 60 seconds) cord clamping, Delayed (≥ 180 seconds) cord clamping
- Keywords
- Resuscitation, Cord clamping
- Medical subject headings
- Infant, Newborn, Diseases, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early (≤ 60 seconds) cord clampingProcedure or surgery
Also called Immediate clamping
If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table
Delayed (≥ 180 seconds) cord clampingProcedure or surgery
Also called Late cord clamping, Deferred cord clamping, Optimal cord clamping
If the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother
| Study group | Role | What they receive |
|---|---|---|
| Early (≤ 60 seconds) cord clamping | Active comparator | Early (≤ 60 seconds) cord clamping Receives: Procedure: Early (≤ 60 seconds) cord clamping |
| Delayed cord clamping | Active comparator | Delayed (≥ 180 seconds) cord clamping Receives: Procedure: Delayed (≥ 180 seconds) cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen saturation
Measured with a pulse oximeter
Measured: 10 minutes after birth
Secondary outcomes (14)
Blood oxygen saturation
Measured with a pulse oximeter
Measured: 5 minutes after birth
Timing of reaching > 90 % in oxygen saturation
Measured with a pulse oximeter
Measured: Within 10 minutes after birth
Newborn heart rate
Measured with a pulse oximeter (preferred), fetal heart monitor or manually
Measured: At 1 minute after birth
Newborn heart rate
Measured with a pulse oximeter (preferred), fetal heart monitor or manually
Measured: At 5 minutes after birth
Newborn heart rate
Measured with a pulse oximeter (preferred), fetal heart monitor or manually
Measured: At 10 minutes after birth
Apgar score
Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
Measured: At 1 minute after birth
Apgar score
Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
Measured: At 5 minutes after birth
Apgar score
Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
Measured: At 10 minutes after birth
Pulsatility index
Measured with a pulse oximeter
Measured: At 5 minutes after birth
Pulsatility index
Measured with a pulse oximeter
Measured: At 10 minutes after birth
Timing of establishing spontaneous breathing
Assessed by staff present
Measured: Within 10 minutes after birth
Timing of first cry
Assessed by staff present
Measured: Within 10 minutes after birth
Timing of moving baby from mother to resuscitation table (if applicable
Assessed by staff present
Measured: Within 10 minutes after birth
Rectal temperature
Assessed by staff present
Measured: At 30 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal DisorderStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF, Ministry of Health and Population, Nepal, Swedish Society for Medical Research
- Responsible party
- Sponsor
- Investigators
- Ashish KC, MD PhD, Principal investigator, Uppsala UniversityOla Andersson, MD PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727517
- Sponsor's protocol ID
- NEPRESUSC16
- Acronym
- NepCordIII
- Status last verified
- Oct 2016
- First submitted
- 29 Mar 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Niermeyer S, Velaphi S. Promoting physiologic transition at birth: re-examining resuscitation and the timing of cord clamping. Semin Fetal Neonatal Med. 2013 Dec;18(6):385-92. doi: 10.1016/j.siny.2013.08.008. Epub 2013 Sep 19.
PubMed 24055300Xodo S, Xodo L, Baccarini G, Driul L, Londero AP. Does Delayed Cord Clamping Improve Long-Term (>/=4 Months) Neurodevelopment in Term Babies? A Systematic Review and a Meta-Analysis of Randomized Clinical Trials. Front Pediatr. 2021 Apr 12;9:651410. doi: 10.3389/fped.2021.651410. eCollection 2021.
PubMed 33912524Andersson O, Rana N, Ewald U, Malqvist M, Stripple G, Basnet O, Subedi K, Kc A. Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10 minutes of birth (Nepcord III) - a randomized clinical trial. Matern Health Neonatol Perinatol. 2019 Aug 29;5:15. doi: 10.1186/s40748-019-0110-z. eCollection 2019.
PubMed 31485335
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early or Late Cord Clamping in the Depressed Neonate - a Randomized Controlled Study in a Low-income Facility Setting for Improved Early Neonatal Outcome
- ClinicalTrials.gov ID
- NCT02727517
- Acronym / sponsor ID
- NepCordIII / NEPRESUSC16
- Conditions
- Neonatal Disorder, Asphyxia Neonatorum
- Keywords
- Resuscitation, Cord clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- UNICEF, Ministry of Health and Population, Nepal, Swedish Society for Medical Research
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Apr 2016 (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.
This study evaluates the hypothesis that delayed compared to early umbilical cord clamping will improve neonatal transition in terms of circulation and breathing during resuscitation.
Detailed description
At the time of birth, the infant is still attached to the placenta via the umbilical cord. The infant is usually separated from the placenta by clamping the cord with two clamps. Early cord clamping has been generally advised to be carried out in the first 30 seconds after birth, regardless of whether the cord pulsation has ceased. However, arguments against early cord clamping include the reduction in the amount of placental transfusion and any associated benefits of extra blood volume, as delayed clamping allows time for a transfer of the fetal blood in the placenta to the infant at the time of birth.
The study will evaluate the effect of early versus delayed cord clamping in a low-income setting in children that do not spontaneously start to breathe. The randomized controlled trial will be carried out at Paropakar Maternity and Women's Hospital (PMWH) in Kathmandu.
The trial will fill several important gaps in relation to early and delayed cord clamping and results.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early (≤ 60 seconds) cord clamping | Active comparator | Procedure: Early (≤ 60 seconds) cord clampingEarly (≤ 60 seconds) cord clamping |
| Delayed cord clamping | Active comparator | Procedure: Delayed (≥ 180 seconds) cord clampingDelayed (≥ 180 seconds) cord clamping |
Who may qualify
- Ages
- 33 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborn in need of resuscitation measures (no or irregular breathing despite thorough drying and additional stimulation within one minute after birth)
- Gestational age ≥ 33 weeks
Key exclusion criteria (1 listed)
- Monochorionic twins (from an ultrasound scan) or clinical evidence of twin-twin transfusion syndrome, triplets or higher order multiple pregnancy, and fetuses with known congenital malformation
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 (≤ 60 seconds) cord clampingAlso: Immediate clampingIf the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table | Procedure or surgery | Early (≤ 60 seconds) cord clamping |
| Delayed (≥ 180 seconds) cord clampingAlso: Late cord clamping, Deferred cord clamping, Optimal cord clampingIf the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother | Procedure or surgery | Delayed cord clamping |
Primary outcome
Blood oxygen saturation
Time frame: 10 minutes after birth
Measured with a pulse oximeter
14 secondary outcomes
Blood oxygen saturation
Time frame: 5 minutes after birth
Timing of reaching > 90 % in oxygen saturation
Time frame: Within 10 minutes after birth
Newborn heart rate
Time frame: At 1 minute after birth
Newborn heart rate
Time frame: At 5 minutes after birth
Newborn heart rate
Time frame: At 10 minutes after birth
Apgar score
Time frame: At 1 minute after birth
Apgar score
Time frame: At 5 minutes after birth
Apgar score
Time frame: At 10 minutes after birth
Pulsatility index
Time frame: At 5 minutes after birth
Pulsatility index
Time frame: At 10 minutes after birth
Timing of establishing spontaneous breathing
Time frame: Within 10 minutes after birth
Timing of first cry
Time frame: Within 10 minutes after birth
Timing of moving baby from mother to resuscitation table (if applicable
Time frame: Within 10 minutes after birth
Rectal temperature
Time frame: At 30 minutes after 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 31 Oct 2016.
- Background: PubMed 24055300Niermeyer S, Velaphi S. Promoting physiologic transition at birth: re-examining resuscitation and the timing of cord clamping. Semin Fetal Neonatal Med. 2013 Dec;18(6):385-92. doi: 10.1016/j.siny.2013.08.008. Epub 2013 Sep 19.
- Derived from this study: PubMed 33912524Xodo S, Xodo L, Baccarini G, Driul L, Londero AP. Does Delayed Cord Clamping Improve Long-Term (>/=4 Months) Neurodevelopment in Term Babies? A Systematic Review and a Meta-Analysis of Randomized Clinical Trials. Front Pediatr. 2021 Apr 12;9:651410. doi: 10.3389/fped.2021.651410. eCollection 2021.
- Derived from this study: PubMed 31485335Andersson O, Rana N, Ewald U, Malqvist M, Stripple G, Basnet O, Subedi K, Kc A. Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10 minutes of birth (Nepcord III) - a randomized clinical trial. Matern Health Neonatol Perinatol. 2019 Aug 29;5:15. doi: 10.1186/s40748-019-0110-z. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Ashish KC, MD PhD principal investigator
Uppsala University
Ola Andersson, MD PhD principal investigator
Uppsala University
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 (≤ 60 seconds) cord clamping and Delayed (≥ 180 seconds) cord clamping in people with Neonatal Disorder and Asphyxia Neonatorum, run by Uppsala University at 1 site in Nepal.
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 2 inclusion and 1 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 31 Oct 2016. 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 Nepal. 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?
Blood oxygen saturation (time frame: 10 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727517, which also lists 3 linked publications.
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 31 Oct 2016.