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Transient Tachypnea of the NewbornPhyCord1NCT06278415

Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery

A study testing Physiological based cord clamping and Differed cord clamping in people with Transient Tachypnea of the Newborn, run by Queen Fabiola Children's University Hospital at 2 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. Read more about this study

Who is it for?
Ages 37 to 42 weeks
Conditions the study is for
Transient Tachypnea of the Newborn
What is being tested?
Physiological based cord clamping and Differed cord clamping
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesBelgium
Study dates
21 Jan 2024to Sep 2024
Phase
Interventional
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 37 to 42 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Pregnant women followed-up in Brugmann University Hospital will be eligible to participate if:
  • Scheduled for cesarean delivery (business days and daily working hours)
  • Singleton pregnancy
  • Cesarean section scheduled at or after 37 weeks gestational age

Who cannot join

  • Fetal anomalies (congenital malformations, anemia, growth restriction with abnormal Dopplers)
  • Abnormal placentation (placenta previa)
  • Signs of fetal distress necessitating an emergency cesarean section
  • Spontaneous labor before cesarean section
  • Maternal health issue including severe anemia (defined as hemoglobin level < 7 g/dL), preeclampsia, and bleeding disorders
  • Maternal refusal of the use of blood products.
Show all 9Show fewer
  • General anesthesia for cesarian section
  • Planned cord blood banking
  • Total language barrier without possibility of translation

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites, 2 recruiting
  • CHU Brugmann

    Brussels, 1020

    Andrew CARLIN, +3224773295, andrew.carlin@chu-brugmann.be

    Andrew CARLIN, MD

    Recruiting
  • Hôpital Universitair Des Enfants Reine Fabiola

    Brussels, 1020

    Anna AMORUSO, +3224773250, anna.amoruso@hubruxelles.be

    Anna AMORUSO, MD

    Recruiting

Other trials in Belgium

About this study

Official title: Pilot Prospective Unblinded Randomized Controlled Study Assessing the Efficacy and Safety of Physiologically Based Cord Clamping Versus Standard Delayed Cord Clamping After Elective Scheduled Cesarean Delivery of Full-term Newborn

Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way. Some babies need to be delivered via cesarean section, a surgical delivery requiring incisions through the abdominal and uterine walls. After cesarean section, the mother is often unable to hold the baby close right away as a result of her own post-surgical care. Moreover, a baby born by planned cesarean section may have breathing problems because of extra fluid staying in the lungs. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after cesarean section while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in term infants born by planned cesarean section and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother.

Read the detailed description

The successful transition from fetal to neonatal life is a major physiological challenge that requires the coordination of lung developmental processes, which culminate with the formation of a diffusible alveolar-capillary barrier, adequate pulmonary vasoreactivity, mature surfactant system, and clearance of lung fluid. During fetal life, gas exchange does not take place in fetal lungs but in the placenta. High pulmonary vascular resistance diverts blood flow to the left atrium through the foramen ovale and to the aorta via the ductus arteriosus. The placental circulation receives 30-50 % of the fetal cardiac output and is the major source of venous return to the fetal heart. Therefore, the umbilical venous return determines the preload for the left ventricle. Shortly before birth and during labor, the lungs undergo important transitional changes. The reabsorption of lung fluid within the airways is initiated during labor by adrenaline-induced activation of sodium channels. Uterine contractions during labor and the onset of inspiration after umbilical cord clamping generate a high transpulmonary pressure gradient leading to additional clearance of fluid from the airways into the surrounding tissue . Following the first breath and lung aeration, oxygen-induced vasodilation leads to a sudden rise in pulmonary blood flow and left atrial pressures, which closes the foramen ovale. Meanwhile, systemic vascular resistance increases above the level of pulmonary vascular resistance after placental removal, which reverses blood flow across the ductus arteriosus and induces ductal closure in response to high oxygen tension.

The route of delivery can impact the success of adaptation to extrauterine life. Over the past 30 years, the rate of cesarean deliveries has increased worldwide. In Belgium, this can be as high as 20% of all deliveries. A subset of cesarean deliveries is scheduled in term infants in the absence of spontaneous labor when vaginal delivery is considered as too risky for maternal and/or child health. The so-called iterative cesarean delivery, which is usually considered as a routine and harmless option, can however alter neonatal health. By contrast with vaginal delivery, infants born at term by iterative cesarean delivery have to adapt despite larger volumes of fluid within airways and interstitial tissue resulting from a limited rise in transpulmonary pressure and adrenaline-induced fluid reabsorption. Subsequently, the retention of lung fluid is responsible for transient tachypnea of the newborn, a respiratory distress that is usually considered as mild, transient, and without sequelae. Moreover, infants born by elective cesarean delivery exhibit a higher risk of positive pressure ventilation resuscitation at birth, admission to the neonatal intensive care unit (NICU), and severe hypoxic respiratory failure requiring mechanical ventilation in the most severe cases. In addition to increased neonatal morbidity, iterative cesarean section can impact mother-infant relationship. After vaginal delivery, immediate skin-to-skin contact during the first minute after birth is the natural process recommended to support mother-infant bonding and promote early onset of breastfeeding. Despite efforts made to start skin-to-skin contact as early as possible after cesarean delivery, immediate contact is practically difficult to implement. In our institution, the infant is usually shortly separated from the mother after umbilical cord clamping to provide first care by a pediatrician before returning on the mother's chest or on the father's chest depending on parental wishes and maternal well-being during the operation. The separation between the mother and her newborn can be further extended in the case of NICU admission for transient tachypnea.

Beside the route of delivery, the timing of umbilical cord clamping can profoundly affect the process of neonatal cardiorespiratory transition. Immediate cord clamping reduces the venous return to the heart, which transiently decreases heartbeats, cardiac output and cerebral blood flow before respiration initiates and pulmonary blood flow increases. Delayed cord clamping for longer than 60 seconds improves the transfusion of blood from the placenta to the newborn. Moreover, it can increase neonatal hemoglobin levels, improve long-term iron stores, and improve neurodevelopmental outcomes. Nevertheless, in both clinical research setting and daily practice, delayed cord clamping lasts rarely more than one minute during cesarean section. More recently, another approach, referred to as physiologically based cord clamping (PBCC), has been proposed to delay cord clamping up to 5 minutes after the onset of ventilation. PBCC allows to start lung aeration while on placental support and, therefore, promotes hemodynamic transition by increasing pulmonary blood flow and maintaining left ventricle preload. This strategy has been demonstrated efficient in preterm lambs and is feasible in very preterm infants, via the use of a purpose-designed resuscitation table that allows delayed cord clamping, maintenance of body temperature, and concomitant respiratory support where necessary. First experience has reported good parental acceptance of the procedure. Because PBCC has not been reported in term infants at risk of respiratory distress after birth, the present project aims to assess whether PBCC in term infants born by elective cesarean section would not be inferior to standard umbilical cord clamping with regards to adaptation to extrauterine life, respiratory morbidity, quality of mother-infant bonding, and maternal safety.

Being tested
Physiological based cord clamping, Differed cord clamping
Keywords
Full-term baby, Scheduled c-section, Neonatal respiratory morbidity, Physiological based-cord clamping
Medical subject headings
Transient Tachypnea of the Newborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physiological based cord clampingOther

    see Arm Description

  • Differed cord clampingOther

    see Arm Description

Study groups in NCT06278415
Study groupRoleWhat they receive
Physiological based cord clamping (PBCC)ExperimentalIn the intervention group, newborns will receive PBCC. The resuscitation table will place in the operating room as close as possible to the mother's pelvis. After the infant is born, the obstetrician holds the infant. Stabilization will start as soon as the infant is placed on the platform. The nurse places the oximeter sensor on the right wrist and ECG electrodes on the chest of the newborn. Local resuscitation guidelines will be in respect of the NLS-ERC 2021 guidelines. Stabilization of the newborn will be performed while the cord is intact and the cord will be clamped after respiratory stabilization will be achieved, defined as the establishment of regular spontaneous breathing, a HR above 100 bpm SpO 2 above 85% while using supplemental oxygen less than 0,3.
Receives: Other: Physiological based cord clamping
Differed cord clamping (DCC)Active comparatorIn the control group, newborns will receive standard DCC defined as time based and performed at 60 seconds after birth. Then infants will be transferred to a standard resuscitation table located in a stabilization room next to the operating room. Further treatment and intervention required for cardiopulmonary stabilization will be provided on the standard resuscitation table. Stabilization will start as soon as the infant is placed on the resuscitation table. The nurse will place the oximeter sensor on the right wrist and ECG electrodes on the chest of the newborn. Local resuscitation guidelines will be in respect of the NLS-ERC 2021 guidelines. The time to reach the stabilisation described above (a HR above 100 bpm and SpO 2 above 85% while using supplemental oxygen less than 0,3) is recorded. Then, the infant will be placed on the mother's chest or partner's chest, or alternatively, be prepared and transferred to the transport incubator if further neonatal care is needed.
Receives: Other: Differed cord clamping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of neonatal mortality

    Measured: within 28 days of delivery

  2. Rate of neonatal resuscitation

    Neonatal resuscitation is defined as the use of a T-piece resuscitator for continuous airway positive pressure or intermittent positive pressure (with or without oxygen supplementation).

    Measured: within first 10 minutes of life

  3. Rate of neonatal respiratory morbidity

    Neonatal respiratory morbidity includes transient tachypnea of the newborn, air leak syndrome and respiratory distress syndrome.

    Measured: within first 24 hours of life

  4. Number of admission to the NICU or special care baby unit

    Measured: within first 72 hours of life

Secondary outcomes (23)
  1. Success of PBCC

    Measured by the percentage of neonates in whom the procedure will be achieved without issue, identification of failed PBCC, and duration of stabilization with PBCC (defined as spontaneous breathing heart rate >100 bpm, oxygen saturation by pulse oximetry ≥ 85% with inspired oxygen fraction < 0.3).

    Measured: within first 10 minutes of life

  2. Time to first breath/cry

    Time in seconds

    Measured: post delivery

  3. Changes in physiological variables during neonatal transition

    Physiological variables include measurements of preductal oxygen saturation by pulse oximetry (in %) and gases, as well as Apgar scores at 1, 5, and 10 minutes.

    Measured: within first 10 minutes of life

  4. Changes in physiological variables during neonatal transition

    Physiological variables include measurements of respiratory rate and heart rate (in number per minute)

    Measured: within first 10 minutes of life

  5. Changes in physiological variables during neonatal transition

    Physiological variables include measurements of body temperature (in degrees Celcius)

    Measured: within first 10 minutes of life

  6. Changes in physiological variables during neonatal transition

    Physiological variables include measurements of umbilical cord venous hemoglobin (in gr/dl)

    Measured: within first 10 minutes of life

  7. Changes in physiological variables during neonatal transition

    Physiological variables include measurements of umbilical cord pH

    Measured: within first 10 minutes of life

  8. Changes in physiological variables during neonatal transition

    Physiological variables include measurements of Apgar scores (from 1 to 10 units on the scale, the highest scores meaning better outcome) at 1, 5 and 10 minutes

    Measured: within first 10 minutes of life

  9. Early neonatal parameters

    Early neonatal parameters include body temperature (in degrees Celcius) at 1, 2 and 3 hours of life.

    Measured: within the first 3 hours of life

  10. Early neonatal parameters

    Early neonatal parameters include body weight (in gramme).

    Measured: within first 24 hours of life

  11. Hemoglobin level

    in g/dl

    Measured: at 48 hours of life

  12. Bilirubin level

    in mg/dl

    Measured: at 48 hours of life

  13. Number of neonatal adverse events

    including hypoglycemia, sepsis, and the need for phototherapy.

    Measured: within first 72 hours of live

  14. Maternal perioperative parameters

    Maternal perioperative parameters include total surgical time (in minutes), intraoperative intravenous fluid volume, intraoperative blood loss, uterotonic administration, and postoperative hemoglobin level at day 1.

    Measured: at Day 1 post delivery

  15. Maternal perioperative parameters

    Maternal perioperative parameters include intraoperative intravenous fluid volume and intraoperative blood loss (in ml), uterotonic administration, and postoperative hemoglobin level at day 1.

    Measured: at Day 1 post delivery

  16. Maternal perioperative parameters

    Maternal perioperative parameters include uterotonic administration (Yes/No), and postoperative hemoglobin level at day 1.

    Measured: at Day 1 post delivery

  17. Maternal perioperative parameters

    Maternal perioperative parameters include postoperative hemoglobin level (in gr/dl).

    Measured: at Day 1 post delivery

  18. Number of maternal adverse events

    Maternal adverse events include death, blood transfusion, postpartum hemorrhage, hysterectomy, admission in the Intensive Care Unit, wound seroma, and wound cellulitis.

    Measured: within first 2 weeks post delivery

  19. Rate of maternal-infant bonding

    breastfeeding (yes/no)

    Measured: up to 2 weeks post delivery

  20. Rate of maternal-infant bonding

    maternal depression (measured by the Edinburgh Postnatal Depression Scale (EPDS) - score min = 0, score max = 30, higher score = worse outcome)

    Measured: at 2 weeks post delivery

  21. Rate of maternal-infant bonding

    maternal depression (measured by the Maternal Infant Bonding Scale (MIBS) - score min = 0, score max = 24, higher score = worse outcome)

    Measured: at 2 weeks post delivery

  22. Child developmental assessment

    The child developmental assessment is done using the Brazelton Neonatal Behavioral Assessment Scale (NBAS) - score min = 1, score max = 6, higher score = better outcome

    Measured: at 2 weeks postnatally

  23. Parental satisfaction survey

    Measured: at 2 weeks post delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start21 Jan 2024
  3. Primary completionAug 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06278415
Sponsor's protocol ID
P2021/Neonat/PhyCord 1
Acronym
PhyCord1
Status last verified
Feb 2024
First submitted
11 Jan 2024
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Physiological based cord clamping and Differed cord clamping in people with Transient Tachypnea of the Newborn, run by Queen Fabiola Children's University Hospital at 2 sites in Belgium.

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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna AMORUSO (+3224773250, anna.amoruso@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of neonatal mortality (time frame: within 28 days of delivery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Feb 2024.

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