Clinical trial NCT03731546: Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
Official title: Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Placental Insufficiency
Placental Transfusion
Keywords: Delayed cord clamping
Preterm Infant
Placental Insufficiency
Intrauterine growth restriction
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 90
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peripheral venous CD34 at admission
timeFrame: first 24 hours of infants' life
Secondary outcomes:
measure: Admission hemoglobin
timeFrame: first 24 hours of infants' life
measure: Hemoglobin at 2 months
timeFrame: 2 months of infants' life
measure: Admission platelets
timeFrame: first 24 hours of infants' life
measure: Admission WBCs
timeFrame: first 24 hours of infants' life
measure: Phototherapy requirements
timeFrame: first 28 days of life
measure: Polycythemia
timeFrame: first 28 days of life
measure: Culture proven sepsis
timeFrame: first 28 days of life
measure: Necrotizing enterocolitis
timeFrame: first 28 days of life
measure: Intraventricular hemorrhage
timeFrame: first 28 days of life
measure: Bronchopulmonary dysplasia
timeFrame: first 70 days of life
measure: Need for nasal CPAP
timeFrame: first 28 days of life
measure: Need for mechanical ventilation
timeFrame: first 28 days of life
measure: Duration of oxygen therapy
timeFrame: first 28 days of life
measure: Need for inotropes
timeFrame: first 28 days of life
measure: Retinopathy of prematurity
timeFrame: first 28 days of life
measure: Need for packed RBCs transfusion
timeFrame: first 28 days of life
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University Children's Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.