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The objective of this clinical trial is to investigate the effects of delayed cord clamping on hyperbilirubinemia, the need for phototherapy, neonatal intensive care (NICU) admission
The study will include term or preterm infants born to Rh negative mother.
The enrolled infants will be randomized into two groups:
Group (1) will include infants with delayed cord clamping performed at 60 sec after birth Group (2) will include infants with early cord clamping within 15 seconds.
History and examination The data on the gender, gestational age, birth weight, length, head circumference, 5- minute Apgar scores, presence of jaundice requiring phototherapy or exchange transfusion, need for admission in neonatal intensive care unit, the presence of respiratory distress (RR > 60 breath per minute) ,and length of hospitalization will be recorded.
The enrolled infants will be followed either with their mothers in the nursery or in NICU. Regarding the mothers; maternal age, maternal weight, any diseases, medication, and mode of delivery, and postpartum hemorrhage requiring blood transfusion will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delayed cord clamping | Experimental | DCC performed at 60 sec after birth |
|
| early cord clamping | Experimental | ECC performed at 15 sec after birth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed cord clamping | Procedure | DCC performed at 60 sec after birth |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hematocrit value | Hematocrit will be measured at 2 hours of life (percent %) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Bilirubin level | Bilirubin level will be measured at 24 hours of life (mg/dl) | 24 hours |
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Inclusion Criteria:
- term or preterm infants born to Rh negative mother
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaimaa R Abdelmaksoud, MD | Contact | 01001814411 | 002 | shaimaareda82@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ramadan A Mahmoud, MD | Sohag Faculty of Medicine, Sohag University | Study Chair |
| Rana A Khashaba, MD | Benha Faculty of Medicine, Benha University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University Hospital | Recruiting | Banhā | Qalyubia Governorate | 13512 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26908660 | Background | Garabedian C, Rakza T, Drumez E, Poleszczuk M, Ghesquiere L, Wibaut B, Depoortere MH, Vaast P, Storme L, Houfflin-Debarge V. Benefits of Delayed Cord Clamping in Red Blood Cell Alloimmunization. Pediatrics. 2016 Mar;137(3):e20153236. doi: 10.1542/peds.2015-3236. Epub 2016 Feb 18. | |
| 30288843 | Background | Vural I, Ozdemir H, Teker G, Yoldemir T, Bilgen H, Ozek E. Delayed cord clamping in term large-for-gestational age infants: A prospective randomised study. J Paediatr Child Health. 2019 May;55(5):555-560. doi: 10.1111/jpc.14242. Epub 2018 Oct 4. |
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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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| Early cord clamping |
| Procedure |
ECC performed at 15 sec after birth |
|
| Walid M Tawfik, MD |
| Benha Faculty of Medicine, Benha University |
| Study Chair |