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NCT Number: NCT07699666

Delayed Versus Immediate Cord Clamping in Preterm Birth

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.

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Key information

Conditions

Preterm Birth Complication Anemia Anemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cord Clamping Delayed Cord Clamping Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Fetofetal Transfusion Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hyaline Membrane Disease Infant, Newborn, Diseases Infant, Premature, Diseases Intestinal Diseases Intraventricular Hemorrhage Neonatal Lung Diseases NEC - Necrotizing Enterocolitis Neonatal Morbidity and Mortality Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Neonatal Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Urogenital Diseases

Age range

0 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternity and neonatology center of Tunis

Tunis, Tunis Governorate, 1007, Tunisia

Location status: Recruiting

Location contact

Mohammed Amine Hannachi

CONTACT

[email protected]

99696332

Mohammed Amine MA Hannachi, Assistant Professor

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Delayed umbilical cord clamping

Procedure

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 clamping

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Neonatal Anemia

    Time frame: Within 24-48 hours of birth and if possible 3 to 4 months after birth

    Hemoglobin concentration below the predefined threshold for gestational age or need for red blood cell transfusion during the early neonatal period.

  2. Necrotizing Enterocolitis (NEC)

    Time frame: From Birth up to 28 days after birth

    Incidence of necrotizing enterocolitis stage ≥ II (Bell's classification) in preterm infants.

  3. Intraventricular Hemorrhage (IVH)

    Time frame: Within first 7 days of life

    Presence of intraventricular hemorrhage diagnosed by cranial ultrasound, classified according to standard grading system (Papile classification).

  4. Length of Neonatal Intensive Care Unit (NICU) Stay

    Time frame: From Birth up to 28 days after birth

    Duration of admission in neonatal intensive care unit measured in days.

Study contacts

Contact information is provided by the study sponsor or research team.

Khaled Neji, Professor

CONTACT

[email protected]

+21651352742

Mohammed Amine MA Hannachi, Assistant professor

CONTACT

[email protected]

+21699696332

Sponsors and collaborators

Lead sponsor

Faculty of Medicine of Tunis

Other

Registry information

Official study title

Early Neonatal Outcomes After Delayed Versus Immediate Cord Clamping in Preterm Birth: A Comparative Study From A Tunisian Tertiary Maternity Center

Acronym: PREM-CORD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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