Effect of Umbilical Cord Milking Versus Delayed Clamping in Preterm Infants on Cerebral Oxygenation and Ductus Arteriosus Closure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ductus Arteriosus
- Sponsor
- Ain Shams University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- time of functional ductus arteriosus closure
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
All patients will be subjected to the following:
1-Umbilical cord milking or delayed cord clamping according to the ranamization table 2 serial measurement of cerebral tissue oxygenation 3- serial echocardiography for ductus arteriosus (DA)functional closure
Detailed Description
* Study Population: neonates born and admitted to Ain shams university neonatal intensive care units (NICUs). * Inclusion criteria: o Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs. * Exclusion criteria: * Late preterm with gestational age 34-37 weeks. * Term infants with gestational age \> 37 weeks. * NIRS data that was not obtained within 1st hour after birth. * Congenital heart disease (other than DA or small atrial septal defects/patent foramen oval/ventriculi septal defects). * Hypoxic-ischemic insult. * Major congenital deformations. #All participants will be subjected to the following: * Infants will be considered to be randomized at the time of enrolment for: o Delayed cord clamping (DCC) and Umbilical cord milking (UCM) * Near-infrared spectroscopy (NIRS): * In the delivery room: after the intervention (UCM or DCC) the regional cerebral tissue oxygenation (rScO2 ) and cerebral fractional tissue oxygen extraction (c FTOE) will be collected for 10 minutes within 1st hour after birth. * In the neonatal intensive care unit: NIRS data will be collected for 2 hours at 12,24 hours, and 48 hours after birth. * Echocardiography: will be performed at 6, 12, 18, 24, and 48 hours of life by using an ultrasound Doppler machine Mindary.M9. assessment of DA functioning closure by measuring duct diameter and direction of blood flow through it.
Investigators
walaa M Madkoor, MD [walaa madkoor]
Assistant fellow of pediatrics at Ahmed Maher teaching hospital
Ain Shams University
Eligibility Criteria
Inclusion Criteria
- •Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs.
Exclusion Criteria
- •Late preterm with gestational age 35-37 weeks.
- •Term infants with gestational age \> 37weeks.
- •NIRS data that not obtained within 1sthour after birth.
- •Congenital heart disease (other than PDA or small atrial septal defects/patent foramen oval/muscularventriculoseptal defects).
- •Hypoxic-ischemic insult.
- •Major congenital deformations.
Outcomes
Primary Outcomes
time of functional ductus arteriosus closure
Time Frame: 6, 12, 18, 24, and 48 hours of life
performed by follow-up echocardiography using machine Mindary.M9 measuring changes from the baseline blood flow direction through the ductus arteriosus (DA) at 6, 12, 18, 24, 48 hours of life that helps to determine at which time the functional closure of ductus arteriosus occurs.
Secondary Outcomes
- changes in cerebral tissue oxygenation by NIRS.(First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life)
- ductus arteriosus diameter(6, 12, 18, 24, and 48 hours of life)