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To investigate the effect of umbilical cord milking (UCM) on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants ≤ 34 weeks gestational age with placental insufficiency. We hypothesize that UCM would enhance peripheral CD34 concentration, hemoglobin and reduce prematurity complications like NEC and IVH in preterm infant ≤ 34 week gestational age with placental insufficiency.
A pilot prospective randomized controlled study will be conducted among 3 groups, all of them are preterm less than 34 weeks gestational age, in the first group umbilical cord milking will be done for preterm infant with placental insufficiency. Two control groups are present, in the first one umbilical cord milking will be done for preterm infants without placental insufficiency (Insufficiency vs. no insufficiency), another group of immediate cord clamping for preterm infants with placental insufficiency will be added (milking vs. no milking), 30 cases will be recruited in each group.
Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.
One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and CD34 will be assessed by flow cytometry. Secondary outcomes will be documented during NICU stay that include admission CBC, peak bilirubin concentrations, CBC after 2 months, neonatal morbidity such as sepsis, bronchopulmonary dysplasia, necrotizing enterocolitis, retinopathy of prematurity and polycythemia, therapeutic interventions such as need for inotropes, nasal CPAP, mechanical ventilation and phototherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | umbilical cord milking will be done for preterm infants <34 gestational age without placental insufficiency |
|
| Group B | Active Comparator | umbilical cord milking will be done for preterm infant <34 gestational age with placental insufficiency |
|
| Group C | No Intervention | Immediate cord clamping for preterm infants <34 gestational age with placental insufficiency |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Milking | Procedure | Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team. |
| 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 min 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 Hospital | Al Mansurah | El Dakahlya | 35111 | Egypt | ||
| Mansoura University Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29886779 | Result | Li J, Yu B, Wang W, Luo D, Dai QL, Gan XQ. Does intact umbilical cord milking increase infection rates in preterm infants with premature prolonged rupture of membranes? J Matern Fetal Neonatal Med. 2020 Jan;33(2):184-190. doi: 10.1080/14767058.2018.1487947. Epub 2018 Sep 6. | |
| 26519708 | Result | Kumar B, Upadhyay A, Gothwal S, Jaiswal V, Joshi P, Dubey K. Umbilical Cord Milking and Hematological Parameters in Moderate to Late Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2015 Sep;52(9):753-7. doi: 10.1007/s13312-015-0711-1. |
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| ID | Term |
|---|---|
| D010927 | Placental Insufficiency |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D010922 | Placenta Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 after umbilical cord milking |
| 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 hours of life. | first 24 hours of infants' life |
| Phototherapy requirements | Need to start phototherapy for hyperbilirubinemia | first 28 days of life |
| Polycythemia | arterial Hematocrit value more than 70% | first 28 days of life |
| Culture proven sepsis | Sepsis confirmed by positive blood culture | first 28 days of life |
| Necrotizing enterocolitis | Necrotizing enterocolitis (Any Bell's stage) | first 28 days of life |
| Intraventricular hemorrhage | Intraventricular hemorrhage of all grades | first 28 days of life |
| Bronchopulmonary dysplasia | Oxygen requirement at 36 weeks corrected gestational age | first 70 days of life |
| Need for packed RBCs transfusion | number of packed RBCs transfusion | first 28 days of life |
| Retinopathy of prematurity | Prethreshold and threshold diseases Retinopathy of prematurity | first 28 days of life |
| Need for inotropes | Hypotension requiring inotropic support | first 28 days of life |
| Need for nasal CPAP | respiratory distress requiring CPAP support | first 28 days of life |
| Need for mechanical ventilation | respiratory distress requiring mechanical ventilation support | first 28 days of life |
| Duration of oxygen therapy | Duration of oxygen therapy | first 70 days of life |
| Al Mansurah |
| Egypt |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |