Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

Preterm Infant Clinical Trial

Official title:

Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731546
• Other study ID #: MS/17.04.15
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2022
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Minute

Eligibility

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

Related Conditions & MeSH terms

• Placental Insufficiency
• Placental Transfusion
• Premature Birth
• Preterm Infant

Intervention

Procedure:
• Delayed cord clamping
Cord clamping 60 seconds after delivery of fetus in preterm infants

Locations

Country	Name	City	State
Egypt	Mansoura University Children's Hospital	Mansourah

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Children Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Hemoglobin at 2 months	One milliliter of neonatal blood will be taken from peripheral venous blood at 2 months of life.	2 months of infants' life
Secondary	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
Secondary	Admission WBCs	One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24	first 24 hours of infants' life
Secondary	Phototherapy requirements		first 28 days of life
Secondary	Polycythemia		first 28 days of life
Secondary	Culture proven sepsis		first 28 days of life
Secondary	Necrotizing enterocolitis		first 28 days of life
Secondary	Intraventricular hemorrhage		first 28 days of life
Secondary	Bronchopulmonary dysplasia		first 70 days of life
Secondary	Need for nasal CPAP		first 28 days of life
Secondary	Need for mechanical ventilation		first 28 days of life
Secondary	Duration of oxygen therapy		first 28 days of life
Secondary	Need for inotropes		first 28 days of life
Secondary	Retinopathy of prematurity		first 28 days of life
Secondary	Need for packed RBCs transfusion		first 28 days of life