Placental Transfusion Effect on Hemodynamics of Premature Newborns

NCT04811872 | Completed Phase 2

• 1 other identifier: 0106459
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-Term

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Intact umbilical cord milking (I-UCM)

EXPERIMENTAL

Biological: Intact umbilical cord milking (I-UCM)

Cut-umbilical cord milking(C-UCM)

EXPERIMENTAL

Biological: Cut-umbilical cord milking(C-UCM)

Delayed Cord Clamping (DCC )

EXPERIMENTAL

Biological: Delayed Cord Clamping (DCC)

Interventions

Intact umbilical cord milking (I-UCM) BIOLOGICAL

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.

Intact umbilical cord milking (I-UCM)

Cut-umbilical cord milking(C-UCM) BIOLOGICAL

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.

Cut-umbilical cord milking(C-UCM)

Delayed Cord Clamping (DCC) BIOLOGICAL

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.

Delayed Cord Clamping (DCC )

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marwa Mohamed Farag: lead

Study Sites (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, 21131, Egypt

Location

Related Publications (1)

• Farag MM, Thabet MAEH, Abd-Almohsen AM, Ibrahim HIAM. The effect of placental transfusion on hemodynamics in premature newborns: a randomized controlled trial. Eur J Pediatr. 2022 Dec;181(12):4121-4133. doi: 10.1007/s00431-022-04619-0. Epub 2022 Sep 21.

  PMID: 36129535 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 23, 2021
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

EG (1)