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| Name | Class |
|---|---|
| UNICEF | OTHER |
| Ministry of Health and Population, Nepal | OTHER_GOV |
| Swedish Society for Medical Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early (≤ 60 seconds) cord clamping | Active Comparator | Early (≤ 60 seconds) cord clamping |
|
| Delayed cord clamping | Active Comparator | Delayed (≥ 180 seconds) cord clamping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early (≤ 60 seconds) cord clamping | Procedure | If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table |
| Measure | Description | Time Frame |
|---|---|---|
| Blood oxygen saturation | Measured with a pulse oximeter | 10 minutes after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Blood oxygen saturation | Measured with a pulse oximeter | 5 minutes after birth |
| Timing of reaching > 90 % in oxygen saturation | Measured with a pulse oximeter |
| Measure | Description | Time Frame |
|---|---|---|
| Presence at one day of age | The place of stay for newborn at one day of age | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Ashish KC, MD PhD | Uppsala University | Principal Investigator |
| Ola Andersson, MD PhD | Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paropakar Maternity and Women's Hospital | Kathmandu | 44600 | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24055300 | Background | 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. | |
| 33912524 | Derived | Xodo 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. |
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| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D001238 | Asphyxia Neonatorum |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Delayed (≥ 180 seconds) cord clamping | Procedure | 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 |
|
|
| Within 10 minutes after birth |
| Newborn heart rate | Measured with a pulse oximeter (preferred), fetal heart monitor or manually | At 1 minute after birth |
| Newborn heart rate | Measured with a pulse oximeter (preferred), fetal heart monitor or manually | At 5 minutes after birth |
| Newborn heart rate | Measured with a pulse oximeter (preferred), fetal heart monitor or manually | At 10 minutes after birth |
| Apgar score | Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes | At 1 minute after birth |
| Apgar score | Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes | At 5 minutes after birth |
| Apgar score | Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes | At 10 minutes after birth |
| Pulsatility index | Measured with a pulse oximeter | At 5 minutes after birth |
| Pulsatility index | Measured with a pulse oximeter | At 10 minutes after birth |
| Timing of establishing spontaneous breathing | Assessed by staff present | Within 10 minutes after birth |
| Timing of first cry | Assessed by staff present | Within 10 minutes after birth |
| Timing of moving baby from mother to resuscitation table (if applicable | Assessed by staff present | Within 10 minutes after birth |
| Rectal temperature | Assessed by staff present | At 30 minutes after birth |
| 31485335 | Derived | Andersson 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. |