Placental Insufficiency, Placental Transfusion, Preterm Infant
Conditions
Keywords
Delayed cord clamping, Preterm Infant, Placental Insufficiency, Intrauterine growth restriction
Brief summary
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.
Detailed description
• 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.
Interventions
PROCEDUREDelayed cord clamping
Cord clamping 60 seconds after delivery of fetus in preterm infants
Sponsors
Mansoura University Children Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Minutes to 1 Minutes
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 minutes of life and CD34 will be assessed by flow cytometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| Hemoglobin at 2 months | 2 months of infants' life | 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 |
| Need for mechanical ventilation | 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 packed RBCs transfusion | first 28 days of life | — |
| Phototherapy requirements | first 28 days of life | — |
Countries
Egypt
Outcome results
None listed