Newborn; VitalityNCT06405867
The Importance of Delayed Cord Clamping
A study testing delayed cord clamping (> 60 sec) in people with Newborn; Vitality and Iron Deficiency Anemia, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
Trial summary
After birth, the umbilical cord is usually clamped and separated from the placenta within the first 30 seconds. Although the exact time to clamp the umbilical cord is unknown, allowing placental transfusion after birth has many benefits for the newborn. Read more about this study
- Who is it for?
- Ages 1 day to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Newborn; Vitality, Iron Deficiency Anemia
- What is being tested?
- delayed cord clamping (> 60 sec)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 25 Aug 2020
- 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 1 day to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The healthy babies of healthy mothers (no pre-eclampsia, no diabetes, no prolonged rupture of membranes or signs of infection) term (gestational age ≥ 37 weeks) and no additional abnormality were included in the study.
Who cannot join
- . Babies who needed resuscitation were excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe Prof Dr. Suleyman Yalcın City Hospital
Istanbul, N/A (n/a), 34730
About this study
Official title: The Importance of Delayed Cord Clamping: do we Know
After birth, the umbilical cord is usually clamped and separated from the placenta within the first 30 seconds. Although the exact time to clamp the umbilical cord is unknown, allowing placental transfusion after birth has many benefits for the newborn.
Increased bleeding control, which is reported as a maternal complication, has not been found in studies. Approximately 28ml/kg additional blood volume is transferred to the baby with placental transfusion. The hemodynamics of the newborn are positively affected as the blood volume increases the right ventricular volume and the pulmonary pressure begins to decrease with the first breath. In addition, due to this additional blood volume, stem cells and erythrocytes pass through more. There are studies showing that it reduces iron deficiency that occurs in infants at the 4th month. In our study, we aimed to examine the effect of allowing placental transfusion until cord pulsation stopped and the effect of delayed cord clamping on iron deficiency at the 4th month in babies.
Read the detailed description
Healthy term newborns who will be born in our gynecology clinic; type of birth, week of gestation, birth weight, cord clamping time, cord blood gas, APGAR score, complete blood count, maternal complete blood count, maternal complications, baby's first body temperature, postnatal day 3 hematocrit and bilirubin level, diet, phototherapy treatment application Measurements will be determined and evaluated in terms of the baby's condition, monthly routine baby follow-up (anthropometric measurements and physical examination), and routine 4th month iron deficiency screening. These measurements and applications will be made by the baby nurse, pediatric assistant and pediatrician who will be present during the birth.
- Conditions
- Newborn; Vitality, Iron Deficiency Anemia
- Being tested
- delayed cord clamping (> 60 sec)
- Keywords
- Delayed cord clamping, hypothermia, polycythemia, iron deficiency anemia
- Medical subject headings
- Anemia, Iron-Deficiency, Hypothermia, Polycythemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed cord clamping (> 60 sec)Procedure or surgery
Also called cord clamping time
In the DCC group, cord pulse was checked without allowing clamping. Waited until the cord pulse stopped. It was wrapped in a sterile and warm cloth and dried. The cord was clamped when the pulse stopped. The cord clamping time was noted on the case report form. In DCC, the baby was placed on the mother's legs in cesarean section (C/S) births and on the mother's mons pubis region in normal vaginal births. The baby was administered a routine delivery room neonatal resuscitation program (NRP) by the pediatrician. After cord clamping, the baby was handed over to the pediatric team.
| Study group | Role | What they receive |
|---|---|---|
| Early cord clamping (< 30 sec) | Experimental | Regardless of the type of delivery, a stopwatch was started to determine the clamping time by visualizing the baby's shoulder. No intervention was made to the health personnel who gave birth in the ECC group. Routinely, one clamp was clamped close to the baby's umbilicus and the other on the mother's side, with a distance of approximately 5 cm from the first clamp and cut between the two clamps. Cord clamping time was noted on the case report form Receives: Procedure: delayed cord clamping (> 60 sec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron deficiency anemia
In terms of iron deficiency anemia, hb < 11 g/dl and transferrin saturation < 15% criteria were taken as basis
Measured: 4 months
Polycythemia and indirect hyperbilirubinemia
Polycythemia was defined by venous hematocrit above 65%. Hyperbilirubinemia was defined as the nomogram being above the phototherapy threshold value.
Measured: 4 months
Secondary outcomes (1)
Postpartum hemorrhage
Postpartum bleeding greater than 500 ml
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jun 2020
- Primary completion25 Aug 2020
- Study completion25 Aug 2020
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 Newborn; VitalityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This was a single-center, with block randomisation \[1:1\], open-label, parallel group study.
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Sevuk Ozumut, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- Fahri Ovalı, Prof, Study chair, İstanbul medeniyet faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405867
- Sponsor's protocol ID
- SYNEO-02
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fenton C, McNinch NL, Bieda A, Dowling D, Damato E. Clinical Outcomes in Preterm Infants Following Institution of a Delayed Umbilical Cord Clamping Practice Change. Adv Neonatal Care. 2018 Jun;18(3):223-231. doi: 10.1097/ANC.0000000000000492.
PubMed 29794839
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Delayed Cord Clamping: do we Know
- ClinicalTrials.gov ID
- NCT06405867
- Acronym / sponsor ID
- SYNEO-02
- Conditions
- Newborn; Vitality, Iron Deficiency Anemia
- Keywords
- Delayed cord clamping, hypothermia, polycythemia, iron deficiency anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 9 May 2024 (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.
After birth, the umbilical cord is usually clamped and separated from the placenta within the first 30 seconds. Although the exact time to clamp the umbilical cord is unknown, allowing placental transfusion after birth has many benefits for the newborn.
Increased bleeding control, which is reported as a maternal complication, has not been found in studies. Approximately 28ml/kg additional blood volume is transferred to the baby with placental transfusion. The hemodynamics of the newborn are positively affected as the blood volume increases the right ventricular volume and the pulmonary pressure begins to decrease with the first breath. In addition, due to this additional blood volume, stem cells and erythrocytes pass through more. There are studies showing that it reduces iron deficiency that occurs in infants at the 4th month. In our study, we aimed to examine the effect of allowing placental transfusion until cord pulsation stopped and the effect of delayed cord clamping on iron deficiency at the 4th month in babies.
Detailed description
Healthy term newborns who will be born in our gynecology clinic; type of birth, week of gestation, birth weight, cord clamping time, cord blood gas, APGAR score, complete blood count, maternal complete blood count, maternal complications, baby's first body temperature, postnatal day 3 hematocrit and bilirubin level, diet, phototherapy treatment application Measurements will be determined and evaluated in terms of the baby's condition, monthly routine baby follow-up (anthropometric measurements and physical examination), and routine 4th month iron deficiency screening. These measurements and applications will be made by the baby nurse, pediatric assistant and pediatrician who will be present during the birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a single-center, with block randomisation [1:1], open-label, parallel group study.
| Arm | Type | Receives |
|---|---|---|
| Early cord clamping (< 30 sec) | Experimental | Procedure: delayed cord clamping (> 60 sec)Regardless of the type of delivery, a stopwatch was started to determine the clamping time by visualizing the baby's shoulder. No intervention was made to the health personnel who gave birth in the ECC group. Routinely, one clamp was clamped close to the baby's umbilicus and the other on the mother's side, with a distance of approximately 5 cm from the first clamp and cut between the two clamps. Cord clamping time was noted on the case report form |
Who may qualify
- Ages
- 1 day to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The healthy babies of healthy mothers (no pre-eclampsia, no diabetes, no prolonged rupture of membranes or signs of infection) term (gestational age ≥ 37 weeks) and no additional abnormality were included in the study.
Key exclusion criteria (1 listed)
- . Babies who needed resuscitation were excluded from the study
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 |
|---|---|---|
| delayed cord clamping (> 60 sec)Also: cord clamping timeIn the DCC group, cord pulse was checked without allowing clamping. Waited until the cord pulse stopped. It was wrapped in a sterile and warm cloth and dried. The cord was clamped when the pulse stopped. The cord clamping time was noted on the case report form. In DCC, the baby was placed on the mother's legs in cesarean section (C/S) births and on the mother's mons pubis region in normal vaginal births. The baby was administered a routine delivery room neonatal resuscitation program (NRP) by the pediatrician. After cord clamping, the baby was handed over to the pediatric team. | Procedure or surgery | Early cord clamping (< 30 sec) |
Primary outcome
Iron deficiency anemia
Time frame: 4 months
In terms of iron deficiency anemia, hb < 11 g/dl and transferrin saturation < 15% criteria were taken as basis
Polycythemia and indirect hyperbilirubinemia
Time frame: 4 months
Polycythemia was defined by venous hematocrit above 65%. Hyperbilirubinemia was defined as the nomogram being above the phototherapy threshold value.
1 secondary outcome
Postpartum hemorrhage
Time frame: 7 days
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 9 May 2024.
- Results publication: PubMed 29794839Fenton C, McNinch NL, Bieda A, Dowling D, Damato E. Clinical Outcomes in Preterm Infants Following Institution of a Delayed Umbilical Cord Clamping Practice Change. Adv Neonatal Care. 2018 Jun;18(3):223-231. doi: 10.1097/ANC.0000000000000492.
- The Short and Long Term Consequences of Delayed Cord Clamping on Late Pre-Term Infants. International journal of women's healthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Fahri Ovalı, Prof study chair
İstanbul medeniyet faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delayed cord clamping (> 60 sec) in people with Newborn; Vitality and Iron Deficiency Anemia, run by Goztepe Prof Dr Suleyman Yalcın City Hospital 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 1 inclusion and 1 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 9 May 2024. 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?
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?
Iron deficiency anemia (time frame: 4 months). The study lists 2 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 NCT06405867, 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 9 May 2024.