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To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age or less) with placental insufficiency.We hypothesized that preterm infants with placental insufficiency underwent DDC could have better hematologic parameters and hematopoietic progenitor cells compared to immediate cord clamping.
• A prospective randomized controlled study will be performed on preterm infants 34 weeks gestational age or less with placental insufficiency, and those without placental insufficiency where DCC will be performed in both groups. A third group of preterm with placental insufficiency and immediate cord clamping will be performed as a control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | No Intervention | Placental insufficiency and ICC : Immediate cord clamping after delivery of the fetus in preterm infants with placental insufficiency | |
| Group B | Active Comparator | Placental insufficiency and DCC: Cord clamping 60 seconds after delivery of fetus in preterm infants with placental insufficiency |
|
| Group C | Active Comparator | Normal placenta with DCC:Cord clamping 60 seconds after delivery of fetus in preterm infants without placental insufficiency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed cord clamping | Procedure | Cord clamping 60 seconds after delivery of fetus in preterm infants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral venous CD34 at admission | One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 minutes of life and CD34 will be assessed by flow cytometry. | first 24 hours of infants' life |
| Measure | Description | Time Frame |
|---|---|---|
| Admission hemoglobin | One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life. | first 24 hours of infants' life |
| Hemoglobin at 2 months | One milliliter of neonatal blood will be taken from peripheral venous blood at 2 months of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Children's Hospital | Al Mansurah | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21391876 | Background | Gokmen Z, Ozkiraz S, Tarcan A, Kozanoglu I, Ozcimen EE, Ozbek N. Effects of delayed umbilical cord clamping on peripheral blood hematopoietic stem cells in premature neonates. J Perinat Med. 2011 May;39(3):323-9. doi: 10.1515/jpm.2011.021. Epub 2011 Mar 11. | |
| 23168790 | Background | Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D010927 | Placental Insufficiency |
| D005330 | Fetofetal Transfusion |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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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| 2 months of infants' life |
| Admission platelets | One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life. | first 24 hours of infants' life |
| Admission WBCs | One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 | first 24 hours of infants' life |
| Phototherapy requirements | first 28 days of life |
| Polycythemia | first 28 days of life |
| Culture proven sepsis | first 28 days of life |
| Necrotizing enterocolitis | first 28 days of life |
| Intraventricular hemorrhage | first 28 days of life |
| Bronchopulmonary dysplasia | first 70 days of life |
| Need for nasal CPAP | first 28 days of life |
| Need for mechanical ventilation | first 28 days of life |
| Duration of oxygen therapy | first 28 days of life |
| Need for inotropes | first 28 days of life |
| Retinopathy of prematurity | first 28 days of life |
| Need for packed RBCs transfusion | first 28 days of life |
| 32623628 | Derived | Yunis M, Nour I, Gibreel A, Darwish M, Sarhan M, Shouman B, Nasef N. Effect of delayed cord clamping on stem cell transfusion and hematological parameters in preterm infants with placental insufficiency: a pilot randomized trial. Eur J Pediatr. 2021 Jan;180(1):157-166. doi: 10.1007/s00431-020-03730-4. Epub 2020 Jul 4. |
| D000091642 | Urogenital Diseases |
| D010922 | Placenta Diseases |
| D000751 | Anemia, Neonatal |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005315 | Fetal Diseases |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |