Preterm Birth ComplicationPREM-CORDNCT07699666
Delayed Versus Immediate Cord Clamping in Preterm Birth
A study testing Delayed Umbilical Cord Clamping and Immediate Umbilical Cord Clamping in people with Preterm Birth Complication and Neonatal Morbidity and Mortality, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
Trial summary
The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth. Preterm infants are at higher risk of neonatal complications, and the timing of cord clamping may influence placental transfusion and neonatal adaptation after birth. Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Preterm Birth Complication, Neonatal Morbidity and Mortality, Cord Clamping
- What is being tested?
- Delayed Umbilical Cord Clamping and Immediate Umbilical Cord Clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Oct 2025to 31 Dec 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 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm neonates born at gestational age between 32 and 37 weeks
- Live-born infants delivered in the study center
- Singleton pregnancies
- Parental consent obtained when applicable according to institutional ethical requirements
Who cannot join
- Major congenital malformations or chromosomal abnormalities
- Need for immediate advanced resuscitation at birth
- Severe fetal distress requiring emergency obstetric intervention incompatible with protocol allocation
- Placental conditions contraindicating delayed cord clamping (e.g., placental abruption with maternal instability, placenta previa bleeding, Placenta accreta spectrum)
- Intra Uterin Growth Restriction with abnormal umbilical artery Doppler velocimetry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohammed Amine MA Hannachi, Assistant professor contact
Tunisia1 site, 1 recruiting
- Recruiting
Maternity and neonatology center of Tunis
Tunis, Tunis Governorate, 1007
Mohammed Amine Hannachi, 99696332, medaminehannachi3@gmail.com
medaminehannachi3@gmail.com
About this study
Official title: Early Neonatal Outcomes After Delayed Versus Immediate Cord Clamping in Preterm Birth: A Comparative Study From A Tunisian Tertiary Maternity Center
The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.
Preterm infants are at higher risk of neonatal complications, and the timing of cord clamping may influence placental transfusion and neonatal adaptation after birth. Delayed cord clamping may increase blood volume, improve iron stores, and reduce some neonatal morbidities, while immediate cord clamping is still commonly practiced in many settings.
Read more
In this study, preterm newborns are assigned to either delayed or immediate cord clamping according to a predefined protocol. Early neonatal outcomes, including respiratory status, need for resuscitation, hemoglobin levels, and early morbidity and mortality, will be assessed.
The study is conducted in a tertiary maternity center in Tunisia.
- Conditions
- Preterm Birth Complication, Neonatal Morbidity and Mortality, Cord Clamping, Delayed Cord Clamping, Anemia, NEC - Necrotizing Enterocolitis
- Being tested
- Delayed Umbilical Cord Clamping, Immediate Umbilical Cord Clamping
- Keywords
- Delayed cord clamping, Immediate cord clamping, Preterm infants, Preterm birth, Umbilical cord clamping, Neonatal outcomes, Placental transfusion, Neonatal morbidity, Neonatal mortality, Tunisia
- Medical subject headings
- Anemia, Enterocolitis, Necrotizing, Hyaline Membrane Disease, Premature Birth, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Umbilical Cord ClampingProcedure or surgery
Delayed umbilical cord clamping is performed in preterm infants by delaying umbilical cord clamping for a predefined duration after birth (at least 30 seconds), allowing continued placental transfusion prior to neonatal separation from the placenta. The procedure is applied immediately after delivery, with neonatal stabilization provided according to standard clinical practice.
Immediate Umbilical Cord ClampingProcedure or surgery
Immediate umbilical cord clamping is performed in preterm infants by clamping the umbilical cord shortly after birth without intentional delay, typically within seconds following delivery, before significant placental transfusion occurs. Neonatal care is initiated immediately after clamping according to standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Umbilical Cord Clamping | Experimental | Delayed umbilical cord clamping is performed in preterm infants according to the study protocol. The umbilical cord is clamped after a predefined delay following birth (at least 30 seconds), allowing continued placental transfusion to the neonate before cord clamping. The intervention is applied immediately after delivery while ensuring neonatal stabilization according to standard clinical practice. Receives: Procedure: Delayed Umbilical Cord Clamping |
| Immediate Umbilical Cord Clamping | Experimental | Immediate umbilical cord clamping is performed in preterm infants according to standard practice. The umbilical cord is clamped shortly after birth without intentional delay, typically within seconds of delivery, before significant placental transfusion occurs. Neonatal care is provided immediately after clamping according to routine clinical protocols. Receives: Procedure: Immediate Umbilical Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Mortality
Death of the neonate occurring within the first 7 days of life or during initial hospitalization in preterm infants allocated to delayed versus immediate umbilical cord clamping.
Measured: Within 7 days of birth (or until hospital discharge, whichever occurs first)
Secondary outcomes (4)
Neonatal Anemia
Hemoglobin concentration below the predefined threshold for gestational age or need for red blood cell transfusion during the early neonatal period.
Measured: Within 24-48 hours of birth and if possible 3 to 4 months after birth
Necrotizing Enterocolitis (NEC)
Incidence of necrotizing enterocolitis stage ≥ II (Bell's classification) in preterm infants.
Measured: From Birth up to 28 days after birth
Intraventricular Hemorrhage (IVH)
Presence of intraventricular hemorrhage diagnosed by cranial ultrasound, classified according to standard grading system (Papile classification).
Measured: Within first 7 days of life
Length of Neonatal Intensive Care Unit (NICU) Stay
Duration of admission in neonatal intensive care unit measured in days.
Measured: From Birth up to 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start2 Oct 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Preterm Birth ComplicationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group interventional study with a 1:1 allocation ratio. Preterm neonates are assigned to either delayed or immediate umbilical cord clamping according to the study protocol. Each infant is exposed to only one intervention at birth, and no crossover is permitted. The two groups are followed prospectively to assess early neonatal outcomes, including respiratory adaptation, need for resuscitation, and early morbidity and mortality.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Amine HANNACHI, Faculty of Medicine of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699666
- Sponsor's protocol ID
- PREM-CORD
- Acronym
- PREM-CORD
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McDonald SD, Narvey M, Ehman W, Jain V, Cassell K. Guideline No. 424: Umbilical Cord Management in Preterm and Term Infants. J Obstet Gynaecol Can. 2022 Mar;44(3):313-322.e1. doi: 10.1016/j.jogc.2022.01.007.
PubMed 35300830Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Jan;218(1):1-18. doi: 10.1016/j.ajog.2017.10.231. Epub 2017 Oct 30.
PubMed 29097178Guideline: Delayed Umbilical Cord Clamping for Improved Maternal and Infant Health and Nutrition Outcomes. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK310511/
PubMed 26269880Ghirardello S, Di Tommaso M, Fiocchi S, Locatelli A, Perrone B, Pratesi S, Saracco P. Italian Recommendations for Placental Transfusion Strategies. Front Pediatr. 2018 Dec 3;6:372. doi: 10.3389/fped.2018.00372. eCollection 2018.
PubMed 30560107Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
PubMed 33773829Kc A, Malqvist M, Rana N, Ranneberg LJ, Andersson O. Effect of timing of umbilical cord clamping on anaemia at 8 and 12 months and later neurodevelopment in late pre-term and term infants; a facility-based, randomized-controlled trial in Nepal. BMC Pediatr. 2016 Mar 10;16:35. doi: 10.1186/s12887-016-0576-z.
PubMed 26965317ACOG Clinical Practice Update: An Update to Clinical Guidance for Delayed Umbilical Cord Clamping After Birth in Preterm Neonates. Obstet Gynecol. 2025 Jul 24;146(3):442-444. doi: 10.1097/AOG.0000000000006020.
PubMed 40706055
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Neonatal Outcomes After Delayed Versus Immediate Cord Clamping in Preterm Birth: A Comparative Study From A Tunisian Tertiary Maternity Center
- ClinicalTrials.gov ID
- NCT07699666
- Acronym / sponsor ID
- PREM-CORD / PREM-CORD
- Conditions
- Preterm Birth Complication, Neonatal Morbidity and Mortality, Cord Clamping, Delayed Cord Clamping, Anemia, NEC - Necrotizing Enterocolitis
- Keywords
- Delayed cord clamping, Immediate cord clamping, Preterm infants, Preterm birth, Umbilical cord clamping, Neonatal outcomes, Placental transfusion, Neonatal morbidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Faculty of Medicine of TunisUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 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.
The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.
Preterm infants are at higher risk of neonatal complications, and the timing of cord clamping may influence placental transfusion and neonatal adaptation after birth. Delayed cord clamping may increase blood volume, improve iron stores, and reduce some neonatal morbidities, while immediate cord clamping is still commonly practiced in many settings.
In this study, preterm newborns are assigned to either delayed or immediate cord clamping according to a predefined protocol. Early neonatal outcomes, including respiratory status, need for resuscitation, hemoglobin levels, and early morbidity and mortality, will be assessed.
The study is conducted in a tertiary maternity center in Tunisia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel-group interventional study with a 1:1 allocation ratio. Preterm neonates are assigned to either delayed or immediate umbilical cord clamping according to the study protocol. Each infant is exposed to only one intervention at birth, and no crossover is permitted. The two groups are followed prospectively to assess early neonatal outcomes, including respiratory adaptation, need for resuscitation, and early morbidity and mortality.
| Arm | Type | Receives |
|---|---|---|
| Delayed Umbilical Cord Clamping | Experimental | Procedure: Delayed Umbilical Cord ClampingDelayed umbilical cord clamping is performed in preterm infants according to the study protocol. The umbilical cord is clamped after a predefined delay following birth (at least 30 seconds), allowing continued placental transfusion to the neonate before cord clamping. The intervention is applied immediately after delivery while ensuring neonatal stabilization according to standard clinical practice. |
| Immediate Umbilical Cord Clamping | Experimental | Procedure: Immediate Umbilical Cord ClampingImmediate umbilical cord clamping is performed in preterm infants according to standard practice. The umbilical cord is clamped shortly after birth without intentional delay, typically within seconds of delivery, before significant placental transfusion occurs. Neonatal care is provided immediately after clamping according to routine clinical protocols. |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Preterm neonates born at gestational age between 32 and 37 weeks
- Live-born infants delivered in the study center
- Singleton pregnancies
- Parental consent obtained when applicable according to institutional ethical requirements
Key exclusion criteria (5 listed)
- Major congenital malformations or chromosomal abnormalities
- Need for immediate advanced resuscitation at birth
- Severe fetal distress requiring emergency obstetric intervention incompatible with protocol allocation
- Placental conditions contraindicating delayed cord clamping (e.g., placental abruption with maternal instability, placenta previa bleeding, Placenta accreta spectrum)
- Intra Uterin Growth Restriction with abnormal umbilical artery Doppler velocimetry
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 Umbilical Cord ClampingDelayed umbilical cord clamping is performed in preterm infants by delaying umbilical cord clamping for a predefined duration after birth (at least 30 seconds), allowing continued placental transfusion prior to neonatal separation from the placenta. The procedure is applied immediately after delivery, with neonatal stabilization provided according to standard clinical practice. | Procedure or surgery | Delayed Umbilical Cord Clamping |
| Immediate Umbilical Cord ClampingImmediate umbilical cord clamping is performed in preterm infants by clamping the umbilical cord shortly after birth without intentional delay, typically within seconds following delivery, before significant placental transfusion occurs. Neonatal care is initiated immediately after clamping according to standard practice. | Procedure or surgery | Immediate Umbilical Cord Clamping |
Primary outcome
Neonatal Mortality
Time frame: Within 7 days of birth (or until hospital discharge, whichever occurs first)
Death of the neonate occurring within the first 7 days of life or during initial hospitalization in preterm infants allocated to delayed versus immediate umbilical cord clamping.
4 secondary outcomes
Neonatal Anemia
Time frame: Within 24-48 hours of birth and if possible 3 to 4 months after birth
Necrotizing Enterocolitis (NEC)
Time frame: From Birth up to 28 days after birth
Intraventricular Hemorrhage (IVH)
Time frame: Within first 7 days of life
Length of Neonatal Intensive Care Unit (NICU) Stay
Time frame: From Birth up to 28 days 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 13 Jul 2026.
- Background: PubMed 35300830McDonald SD, Narvey M, Ehman W, Jain V, Cassell K. Guideline No. 424: Umbilical Cord Management in Preterm and Term Infants. J Obstet Gynaecol Can. 2022 Mar;44(3):313-322.e1. doi: 10.1016/j.jogc.2022.01.007.
- Background: PubMed 29097178Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Jan;218(1):1-18. doi: 10.1016/j.ajog.2017.10.231. Epub 2017 Oct 30.
- Background: PubMed 26269880Guideline: Delayed Umbilical Cord Clamping for Improved Maternal and Infant Health and Nutrition Outcomes. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK310511/
- Background: PubMed 30560107Ghirardello S, Di Tommaso M, Fiocchi S, Locatelli A, Perrone B, Pratesi S, Saracco P. Italian Recommendations for Placental Transfusion Strategies. Front Pediatr. 2018 Dec 3;6:372. doi: 10.3389/fped.2018.00372. eCollection 2018.
- Background: PubMed 33773829Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
- Background: PubMed 26965317Kc A, Malqvist M, Rana N, Ranneberg LJ, Andersson O. Effect of timing of umbilical cord clamping on anaemia at 8 and 12 months and later neurodevelopment in late pre-term and term infants; a facility-based, randomized-controlled trial in Nepal. BMC Pediatr. 2016 Mar 10;16:35. doi: 10.1186/s12887-016-0576-z.
- Background: PubMed 40706055ACOG Clinical Practice Update: An Update to Clinical Guidance for Delayed Umbilical Cord Clamping After Birth in Preterm Neonates. Obstet Gynecol. 2025 Jul 24;146(3):442-444. doi: 10.1097/AOG.0000000000006020.
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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.
Mohammed Amine MA Hannachi, Assistant professor contact
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 Umbilical Cord Clamping and Immediate Umbilical Cord Clamping in people with Preterm Birth Complication and Neonatal Morbidity and Mortality, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
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 5 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: looking for participants now, as of the sponsor's last update on 13 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 Tunisia. 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?
Contact Mohammed Amine MA Hannachi, Assistant professor (+21699696332, mohammedamine.hannachi@fmt.utm.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Mortality (time frame: Within 7 days of birth (or until hospital discharge, whichever occurs first)). 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 NCT07699666, which also lists 7 linked publications.
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 13 Jul 2026.