Pre-TermPhase 2/3NCT04811872
Placental Transfusion Effect on Hemodynamics of Premature Newborns
A Phase 2/3 study testing Intact umbilical cord milking (I-UCM), Cut-umbilical cord milking(C-UCM) and Delayed Cord Clamping (DCC) in people with Pre-Term, run by Marwa Mohamed Farag at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Pre-Term
- What is being tested?
- Intact umbilical cord milking (I-UCM), Cut-umbilical cord milking(C-UCM) and Delayed Cord Clamping (DCC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Oct 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature neonates ≤ 32 weeks gestational age regardless birth weight who will be admitted to neonatal intensive care unit in the first day of life.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Alexandria, 21131
About this study
Official title: Evaluation of the Effect of Placental Transfusion on Hemodynamics in Premature Newborns
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.
Read the detailed 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.
- Conditions
- Pre-Term
- Being tested
- Intact umbilical cord milking (I-UCM), Cut-umbilical cord milking(C-UCM), Delayed Cord Clamping (DCC)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intact umbilical cord milking (I-UCM) | Experimental | Not described Receives: Biological: Intact umbilical cord milking (I-UCM) |
| Cut-umbilical cord milking(C-UCM) | Experimental | Not described Receives: Biological: Cut-umbilical cord milking(C-UCM) |
| Delayed Cord Clamping (DCC ) | Experimental | Not described Receives: Biological: Delayed Cord Clamping (DCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 3 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-TermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marwa Mohamed Farag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Mohamed Farag, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811872
- Sponsor's protocol ID
- 0106459
- Status last verified
- Jun 2022
- First submitted
- 11 Mar 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36129535
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Placental Transfusion on Hemodynamics in Premature Newborns
- ClinicalTrials.gov ID
- NCT04811872
- Acronym / sponsor ID
- 0106459
- Conditions
- Pre-Term
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Marwa Mohamed FaragUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature neonates ≤ 32 weeks gestational age regardless birth weight who will be admitted to neonatal intensive care unit in the first day of life.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Intact umbilical cord milking (I-UCM) |
| 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. | Biological | Cut-umbilical cord milking(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. | Biological | Delayed Cord Clamping (DCC ) |
Primary outcome
Evaluation of superior vena cava flow (SVC) flow by echocardiography
Time frame: up to 3 days of life
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.
Measurement of fractional shortening (FS) by echocardiography
Time frame: up to 3 days of life
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
Evaluation of ejection fraction (EF) by echocardiography
Time frame: up to 3 days of life
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
Evaluation of the pulse wave by echocardiography
Time frame: up to 3 days of life
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.
Evaluation of left ventricular diastolic function by echocardiography
Time frame: up to 3 days of life
The mitral E/A ratio and velocity will be done for assessment of left ventricular diastolic function.
Evaluation of cardiac output (CO)
Time frame: up to 3 days of life
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
Evaluation of patent ductus arteriosus (PDA)
Time frame: up to 3 days of life
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 36129535Farag 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.
Related trials for Pre-Term
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intact umbilical cord milking (I-UCM), Cut-umbilical cord milking(C-UCM) and Delayed Cord Clamping (DCC) in people with Pre-Term, run by Marwa Mohamed Farag at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of superior vena cava flow (SVC) flow by echocardiography (time frame: up to 3 days of life). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04811872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.