Placental Transfusion Effect on Hemodynamics of Premature Newborns

Pre-Term Clinical Trial

Official title:

Evaluation of the Effect of Placental Transfusion on Hemodynamics in Premature Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811872
• Other study ID #: 0106459
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: June 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to perform ultrasound Doppler measurements to evaluate the hemodynamic changes associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life.

Description:

This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

Inclusion Criteria:

• Premature neonates = 32 weeks gestational age regardless birth weight who will be admitted to neonatal intensive care unit in the first day of life.

Exclusion Criteria:

• Preterm babies >32 weeks

• Major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies).

• Evidence of head trauma causing major intracranial hemorrhage.

• Monochorionic multiples.

• Concern for abruptions, placenta previa or retroplacental hematoma.

• Cord accident, or avulsion at the time of delivery.

• Refusal to perform the intervention by the obstetrician

Related Conditions & MeSH terms

• Pre-Term
• Premature Birth

Intervention

Biological:
• Intact umbilical cord milking (I-UCM)
Umblical cord milking will be performed by holding the newborn at or ~20 cm below the level of the placenta. The cord will be pinched between 2 fingers as close to the placenta as possible and milked toward the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 1- to 2-second pause between each milking motion. This will be repeated for 2-4 times. After completion, the cord will be clamped, and the neonate will be handed to the resuscitation team.
• Cut-umbilical cord milking(C-UCM)
This technique involves clamping and cutting a long segment of the umbilical cord immediately at birth and passing the baby and the long cord to the pediatric provider, called C-UCM untwists the cord and milks the entire contents into the baby. Milking the cord 2-3 times before clamping may produce a similar placental transfusion as C-UCM.
• Delayed Cord Clamping (DCC)
Infants placed on the maternal abdomen or at the introitus below the level of placenta and waiting at least 30- to 60 seconds before clamping the cord.

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Marwa Mohamed Farag

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of superior vena cava flow (SVC) flow by echocardiography	Infants are placed in supine position on a flat surface and heart is imaged from a low subcostal view. SVC flow is identified by angling the beam anteriorly until the flow into the right atrium from SVC is seen using color Doppler. SVC diameter will be seen from a high parasternal long axis (PLAX) view. The transducer will be placed as close to the midline as possible to acquire directly anteroposterior views of SVC. Maximum and minimum internal diameters will be measured off-line from a frozen 2D image showing the vessel walls at the point where SVC starts to open into the right atrium. Due to the variation in vessel diameter through the cardiac cycle, mean of the maximum and minimum diameter is used for flow calculation. The velocity time integral (VTI) will be calculated from the Doppler velocity tracings and averaged over 5 consecutive cardiac cycles.; SVC flow will be calculated using the Kluckow and Evans method = (VTI × 3.14 × (mean SVC diameter2/4) × heart rate) / body weight.	up to 3 days of life
Primary	Measurement of fractional shortening (FS) by echocardiography	The FS is obtained from M-mode tracings or 2D imaging in the PLAX view at the tips of the mitral valve leaflets or in the parasternal short-axis (PSAX) view at the level of the papillary muscles. The left ventricular M-mode tracing is obtained from the PLAX or PSAX view. The cursor in M-mode should be placed perpendicular to the interventricular septum and posterior wall at the level of the posterior mitral valve leaflet. Left ventricular end-diastolic dimension (LVEDD) and left ventricular end-systolic dimension (LVESD) will be measured, and the FS is calculated using the following equation: FS (%) = (LVEDD - LVESD / LVEDD) × 100	up to 3 days of life
Primary	Evaluation of ejection fraction (EF) by echocardiography	Left ventricular end-diastolic dimension (LVEDD) and left ventricular end-systolic dimension (LVESD) will be measured to calculate the ejection fraction.; The EF is calculated using the following equation: EF (%) = (LVEDV - LVESV/ LVEDV)× 100	up to 3 days of life
Primary	Evaluation of the pulse wave by echocardiography	The pulse wave (PW) Doppler across mitral inflow is composed of two waves: an E wave representing early passive ventricular filling (preload dependent) and an A wave representing late diastolic active filling as a result of atrial contraction.	up to 3 days of life
Primary	Evaluation of left ventricular diastolic function by echocardiography	The mitral E/A ratio and velocity will be done for assessment of left ventricular diastolic function.	up to 3 days of life
Primary	Evaluation of cardiac output (CO)	The echocardiographic assessment of the CO can be obtained by measuring cross-sectional area (CSA) of the left or RV outflow tract at the level of aortic or pulmonary annulus and by measuring the velocity time integral (VTI) at the level of aortic or pulmonary valve by pulsed wave Doppler, respectively. The CO is calculated by using the following equation: Cardiac Output (CO)=SV×HR= VTI× CSA× Heart Rate	up to 3 days of life
Primary	Evaluation of patent ductus arteriosus (PDA)	The left-sided parasternal "ductal" view is the window to obtain a clear 2D image of the ductus arteriosus. The ultrasound probe is placed in a true sagittal plane to the left of the sternum with the marker pointing toward the head to obtain the ductal view. The PDA is visualized as a structure leaving the left side of the junction of the main pulmonary artery and the left pulmonary artery (LPA) toward the descending aorta. Color Doppler may be used to visualize the direction of transductal blood flow. The transdustal diameter will be measured in this view. Velocity and direction of the shunt during the cardiac cycle can be obtained by applying continuous wave.	up to 3 days of life