Newborn InfantCord ClampingNCT07719751
The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
A study testing Prone position and Left side lying position in people with Newborn Infant and Newborn Health, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
During intrauterine life, the fetus is connected to the mother via the placenta; with birth, the extrauterine adaptation process begins. The first six hours after birth are defined as the "adaptation period" for the newborn and consist of three stages. Read more about this study
- Who is it for?
- Ages 0 minutes and olderHealthy volunteers can take part
- Conditions the study is for
- Newborn Infant, Newborn Health, Delayed Cord Clamping
- What is being tested?
- Prone position and Left side lying position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Apr 2026to 2 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 minutes and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The newborn must have been born at term (≥37 weeks)
- Born from a singleton pregnancy
- Born vaginally
- The newborn must have been born alive
- The newborn must have spontaneous breathing
- The 1-minute Apgar score must be ≥7
- The mother must be able to communicate with the research
- The mother must have volunteered to participate in the study and given informed consent
Who cannot join
- Meconium-stained or foul-smelling amniotic fluid
- Episiotomy (3rd and 4th degree) and medical intervention during labor (vacuum, dystocia interventions, etc.)
- Suspicion of congenital anomalies or genetic diseases in the newborn
- History of known chronic diseases in the mother or baby (diabetes, hypertension, epilepsy, thyroid disease, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
During intrauterine life, the fetus is connected to the mother via the placenta; with birth, the extrauterine adaptation process begins. The first six hours after birth are defined as the "adaptation period" for the newborn and consist of three stages. In this process, the first reactive period is particularly critical because the initial assessments determine the newborn's well-being. All organs, especially the respiratory and cardiovascular systems, are rapidly activated, and adaptation parameters are monitored. Evidence-based care interventions applied by midwives during this period directly affect the newborn's physiological stability and long-term health. The timing of umbilical cord clamping is a decisive factor in this adaptation. The World Health Organization recommends waiting at least 1 minute after birth for term and stable preterm infants, ideally with a delay of 1-3 minutes for clamping. Blood flow from the placenta to the baby continues for the first few minutes after birth. Therefore, not clamping the umbilical cord until 2-3 minutes have passed or until the cord pulse has completely stopped provides a physiological blood transfer. In this process, defined as "placental transfusion," a large portion of the blood passes to the baby within the first 3 minutes, contributing to an increase in circulatory volume and hemoglobin levels. In premature infants, stem cell transfer reduces complications and provides long-term benefits. In addition, this practice increases venous return, supporting heart filling and facilitating cardiorespiratory transition. In infants who undergo delayed clamping, oxygen saturation rises faster and irregular heartbeats are less common.
Read the detailed description
Positioning the newborn in parallel with cord clamping also plays a critical role in oxygenation and circulatory balance. The literature has shown that the prone position increases pulmonary ventilation, raises oxygen saturation, and supports cerebral oxygenation. It is reported that it is effective in preventing problems such as apnea, bradycardia, and oxygen imbalance, especially in premature infants; and that it supports calming and motor development due to its similarity to fetal position. The importance of body position becomes even more apparent in optimizing oxygen supply in the fetal and neonatal periods due to the effect of gravity; cardiovascular and cardiopulmonary systems are sensitive to these physiological changes. In this context, appropriate body alignment increases treatment effectiveness and directly affects clinical outcomes, especially in newborns requiring respiratory support. Indeed, it is reported that the prone position, a non-invasive and easily applicable method, is effective in increasing oxygen saturation levels in newborns with respiratory distress syndrome. Positioning in the care of premature infants is central to nursing and midwifery practices and also plays a fundamental role in coordinating all other care processes. The prone position, frequently preferred in neonatal intensive care units, supports pulmonary ventilation by preventing atelectasis development, increasing gas exchange, and preventing aspiration of gastric contents into the lungs. It has also been reported that stable positions such as prone and lateral contribute to the effective removal of respiratory secretions and the increase of arterial oxygen levels; this effect has also been observed in adult intensive care patients. The research conducted aims to evaluate the effects of delivery method, cord clamping time, and delivery room practices on cerebral oxygenation. Most studies have examined term infants who experienced a smooth physiological transition. In evaluations based on cerebral oxygen saturation (CrSO2) and cerebral fractional oxygen extraction (cFTOE) values, it is seen that these parameters reach a certain equilibrium in the first 10-15 minutes of life. These findings highlight the importance of using new indicators in monitoring physiological parameters during the transition period.
- Conditions
- Newborn Infant, Newborn Health, Delayed Cord Clamping
- Being tested
- Prone position, Left side lying position
- Keywords
- Newborn, Prone, Left side lying, Position, Comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionOther
After birth, the newborn will be positioned vertically on the linea line above the mother's mons pubis and monitored while lying prone.
Left side lying positionOther
After birth, the newborn will be positioned vertically on the linea line above the mother's mons pubis and monitored while lying left side.
| Study group | Role | What they receive |
|---|---|---|
| Prone position group | Experimental | Newborns should be placed in a prone position immediately after birth. Receives: Other: Prone position |
| Left Side Lying Position Group | Experimental | Newborns should be placed on their left side immediately after birth. Receives: Other: Left side lying position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate (pulse)
Heart rate will be measured using a pulse oximeter during delayed umbilical cord clamping while the newborn is positioned either in the prone or left lateral position.
Measured: During delayed umbilical cord clamping (within the first minutes after birth)
Secondary outcomes (1)
Oxygen saturation (SpO₂)
Peripheral oxygen saturation will be measured using a pulse oximeter during delayed umbilical cord clamping while the newborn is positioned either in the prone or left lateral position.
Measured: During delayed umbilical cord clamping (within the first minutes after birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start11 Apr 2026
- Primary completion20 Sep 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn InfantStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı EKER, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719751
- Sponsor's protocol ID
- Mersin University 1
- Acronym
- Cord Clamping
- Status last verified
- Jul 2026
- First submitted
- 8 May 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The consent form submitted to the ethics committee provides participants with assurance that their data will not be shared. Therefore, it is not being shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
- ClinicalTrials.gov ID
- NCT07719751
- Acronym / sponsor ID
- Cord Clamping / Mersin University 1
- Conditions
- Newborn Infant, Newborn Health, Delayed Cord Clamping
- Keywords
- Newborn, Prone, Left side lying, Position, Comfort
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 11 Apr 2026 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 22 Jul 2026 (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.
During intrauterine life, the fetus is connected to the mother via the placenta; with birth, the extrauterine adaptation process begins. The first six hours after birth are defined as the "adaptation period" for the newborn and consist of three stages. In this process, the first reactive period is particularly critical because the initial assessments determine the newborn's well-being. All organs, especially the respiratory and cardiovascular systems, are rapidly activated, and adaptation parameters are monitored. Evidence-based care interventions applied by midwives during this period directly affect the newborn's physiological stability and long-term health. The timing of umbilical cord clamping is a decisive factor in this adaptation. The World Health Organization recommends waiting at least 1 minute after birth for term and stable preterm infants, ideally with a delay of 1-3 minutes for clamping. Blood flow from the placenta to the baby continues for the first few minutes after birth. Therefore, not clamping the umbilical cord until 2-3 minutes have passed or until the cord pulse has completely stopped provides a physiological blood transfer. In this process, defined as "placental transfusion," a large portion of the blood passes to the baby within the first 3 minutes, contributing to an increase in circulatory volume and hemoglobin levels. In premature infants, stem cell transfer reduces complications and provides long-term benefits. In addition, this practice increases venous return, supporting heart filling and facilitating cardiorespiratory transition. In infants who undergo delayed clamping, oxygen saturation rises faster and irregular heartbeats are less common.
Detailed description
Positioning the newborn in parallel with cord clamping also plays a critical role in oxygenation and circulatory balance. The literature has shown that the prone position increases pulmonary ventilation, raises oxygen saturation, and supports cerebral oxygenation. It is reported that it is effective in preventing problems such as apnea, bradycardia, and oxygen imbalance, especially in premature infants; and that it supports calming and motor development due to its similarity to fetal position. The importance of body position becomes even more apparent in optimizing oxygen supply in the fetal and neonatal periods due to the effect of gravity; cardiovascular and cardiopulmonary systems are sensitive to these physiological changes. In this context, appropriate body alignment increases treatment effectiveness and directly affects clinical outcomes, especially in newborns requiring respiratory support. Indeed, it is reported that the prone position, a non-invasive and easily applicable method, is effective in increasing oxygen saturation levels in newborns with respiratory distress syndrome. Positioning in the care of premature infants is central to nursing and midwifery practices and also plays a fundamental role in coordinating all other care processes. The prone position, frequently preferred in neonatal intensive care units, supports pulmonary ventilation by preventing atelectasis development, increasing gas exchange, and preventing aspiration of gastric contents into the lungs. It has also been reported that stable positions such as prone and lateral contribute to the effective removal of respiratory secretions and the increase of arterial oxygen levels; this effect has also been observed in adult intensive care patients. The research conducted aims to evaluate the effects of delivery method, cord clamping time, and delivery room practices on cerebral oxygenation. Most studies have examined term infants who experienced a smooth physiological transition. In evaluations based on cerebral oxygen saturation (CrSO2) and cerebral fractional oxygen extraction (cFTOE) values, it is seen that these parameters reach a certain equilibrium in the first 10-15 minutes of life. These findings highlight the importance of using new indicators in monitoring physiological parameters during the transition period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone position group | Experimental | Other: Prone positionNewborns should be placed in a prone position immediately after birth. |
| Left Side Lying Position Group | Experimental | Other: Left side lying positionNewborns should be placed on their left side immediately after birth. |
Who may qualify
- Ages
- 0 minutes and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- The newborn must have been born at term (≥37 weeks)
- Born from a singleton pregnancy
- Born vaginally
- The newborn must have been born alive
- The newborn must have spontaneous breathing
Key exclusion criteria (4 listed)
- Meconium-stained or foul-smelling amniotic fluid
- Episiotomy (3rd and 4th degree) and medical intervention during labor (vacuum, dystocia interventions, etc.)
- Suspicion of congenital anomalies or genetic diseases in the newborn
- History of known chronic diseases in the mother or baby (diabetes, hypertension, epilepsy, thyroid disease, etc.)
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 |
|---|---|---|
| Prone positionAfter birth, the newborn will be positioned vertically on the linea line above the mother's mons pubis and monitored while lying prone. | Other | Prone position group |
| Left side lying positionAfter birth, the newborn will be positioned vertically on the linea line above the mother's mons pubis and monitored while lying left side. | Other | Left Side Lying Position Group |
Primary outcome
Heart rate (pulse)
Time frame: During delayed umbilical cord clamping (within the first minutes after birth)
Heart rate will be measured using a pulse oximeter during delayed umbilical cord clamping while the newborn is positioned either in the prone or left lateral position.
1 secondary outcome
Oxygen saturation (SpO₂)
Time frame: During delayed umbilical cord clamping (within the first minutes after birth)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. The consent form submitted to the ethics committee provides participants with assurance that their data will not be shared. Therefore, it is not being shared.
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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.
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 study testing Prone position and Left side lying position in people with Newborn Infant and Newborn Health, run by Mersin University at 1 site in Turkey (Türkiye).
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 8 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Heart rate (pulse) (time frame: During delayed umbilical cord clamping (within the first minutes after birth)). 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 22 Jul 2026.