Placental Insufficiency, Preterm Infant
Conditions
Keywords
Umbilical cord milking
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREUmbilical Cord Milking
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.
Sponsors
Mansoura University Children Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Minutes to No maximum
Healthy volunteers
No
Inclusion criteria
* preterm neonates \< 34 weeks gestational age
Exclusion criteria
* Vaginal bleeding due to placental abruption or tears * Multiple pregnancies * Suspected major fetal anomalies * Suspected chromosomal aberration * Maternal drug abuse * Hydrops fetalis * preterm who needed major resuscitative measures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral venous CD34 at admission | first 24 hours of infants' life | 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
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin at 2 months | 2 months after umbilical cord milking | One milliliter of neonatal blood will be taken from peripheral venous blood at 2 months of life. |
| Admission platelets | first 24 hours of infants' life | One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life. |
| Admission WBCs | first 24 hours of infants' life | One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life. |
| Phototherapy requirements | first 28 days of life | Need to start phototherapy for hyperbilirubinemia |
| Polycythemia | first 28 days of life | arterial Hematocrit value more than 70% |
| Culture proven sepsis | first 28 days of life | Sepsis confirmed by positive blood culture |
| Necrotizing enterocolitis | first 28 days of life | Necrotizing enterocolitis (Any Bell's stage) |
| Admission hemoglobin | first 24 hours of infants' life | One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life. |
| Bronchopulmonary dysplasia | first 70 days of life | Oxygen requirement at 36 weeks corrected gestational age |
| Need for packed RBCs transfusion | first 28 days of life | number of packed RBCs transfusion |
| Retinopathy of prematurity | first 28 days of life | Prethreshold and threshold diseases Retinopathy of prematurity |
| Need for inotropes | first 28 days of life | Hypotension requiring inotropic support |
| Need for nasal CPAP | first 28 days of life | respiratory distress requiring CPAP support |
| Need for mechanical ventilation | first 28 days of life | respiratory distress requiring mechanical ventilation support |
| Duration of oxygen therapy | first 70 days of life | Duration of oxygen therapy |
| Intraventricular hemorrhage | first 28 days of life | Intraventricular hemorrhage of all grades |
Countries
Egypt
Outcome results
None listed