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Delayed Versus Immediate Cord Clamping in Preterm Birth (PREM-CORD)

8. juli 2026 opdateret af: Mohammed Amine HANNACHI, Faculty of Medicine of Tunis

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.

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Tunesien
    • Tunis Governorate
      • Tunis, Tunis Governorate, Tunesien, 1007

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Delayed Umbilical Cord Clamping
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.
Procedure: Delayed Umbilical Cord Clamping
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.
Eksperimentel: Immediate Umbilical Cord Clamping
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.
Procedure: Immediate Umbilical Cord Clamping
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neonatal Mortality
Tidsramme: 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.
Within 7 days of birth (or until hospital discharge, whichever occurs first)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neonatal Anemia
Tidsramme: 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.
Within 24-48 hours of birth and if possible 3 to 4 months after birth
Necrotizing Enterocolitis (NEC)
Tidsramme: From Birth up to 28 days after birth
Incidence of necrotizing enterocolitis stage ≥ II (Bell's classification) in preterm infants.
From Birth up to 28 days after birth
Intraventricular Hemorrhage (IVH)
Tidsramme: Within first 7 days of life
Presence of intraventricular hemorrhage diagnosed by cranial ultrasound, classified according to standard grading system (Papile classification).
Within first 7 days of life
Length of Neonatal Intensive Care Unit (NICU) Stay
Tidsramme: From Birth up to 28 days after birth
Duration of admission in neonatal intensive care unit measured in days.
From Birth up to 28 days after birth

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Faculty of Medicine of Tunis

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. oktober 2025

Primær færdiggørelse (Anslået)

31. august 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PREM-CORD

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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