NCT03852134

Brief Summary

In this feasibility study, the investigators will randomize preterm infants born at \<32 weeks gestation to either the standard practice of delayed cord clamping (DCC) for 30-60 seconds at birth or milking of the long-cut cord (MOCC) while providing resuscitation/stabilization to the infant. The main objectives of the trial are to assess the feasibility of the new approach (MOCC) and to compare the two groups regarding the hemoglobin levels on admission to NICU in addition to neonatal morbidity and mortality.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2021

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

April 30, 2018

Last Update Submit

February 21, 2019

Conditions

Preterm Infant

Keywords

preterm infantdelayed cord clampingcord milkingresuscitation

Outcome Measures

Primary Outcomes (3)

  • Rate of compliance to the study intervention

    to investigate the adherence to the new approach of MOCC during resuscitation/ stabilization following 30 seconds of DCC in preterm infants.

    Two years

  • Number of patients completing the study

    To evaluate the number of patients who are recruited and completed the study to estimate the sample size needed for the design of a large multi-centre RCT.

    Two years

  • Number of adverse events associated with the MOCC intervention

    To investigate any adverse events that could be attributed to the MOCC intervention.

    Till the participants reach 2 year- corrected age (around 4.5 years)

Secondary Outcomes (1)

  • Compare hemoglobin (Hgb) concentration

    From date of randomization and assessed up to 24 hours of age

Other Outcomes (8)

  • Temperature stability

    From randomization assessed up to 2 hours of age

  • Need for advanced resuscitation at birth

    From randomization assessed up to 2 hours of age

  • Inotropic support

    From randomization assessed up to 72 hours of age

  • +5 more other outcomes

Study Arms (2)

MOCC Group

EXPERIMENTAL

The OB provider will hold the baby at/below the placenta, provide warmth, stimulate the baby and suction the mouth/nose for 30 secs.S/He will then clamp and cut the cord about 5 cm from the the introitus (vaginal deliveries) or from the abdominal incision (C-Sections) before handing the baby with the long-cut cord to the neonatal team to resuscitate/ stabilize the baby. A member of the neonatal team will milk the long-cut cord slowly 1 time from the cut end toward the infant over 10 secs before clamping and cutting the cord 1-2 cm from the umbilical stump. The neonatal team will provide PPV to the baby (during the milking process) if the baby is not breathing. If the baby is breathing during the milking process the team will continue the stabilization as per standard NRP practice.

Procedure: MOCC Group

DCC group

ACTIVE COMPARATOR

The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds. After these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.

Procedure: DCC Group

Interventions

MOCC GroupPROCEDURE

After 30 seconds of DCC, the cord will be clamped and cut 5 cm from the introitus in vaginal delivery or abdominal incision in the case of cesarean section before passing the infant with the long umbilical cord segment to the pediatric provider who will milk the cord one time towards the baby during resuscitation.

Also known as: Monitoring cerebral oxygenation by NIRS
MOCC Group
DCC GroupPROCEDURE

The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds. After these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.

Also known as: Monitoring cerebral oxygenation by NIRS
DCC group

Eligibility Criteria

AgeUp to 1 Minute
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants \<32 weeks' gestation

You may not qualify if:

  • Clinical evidence of interrupted placental circulation (placental abruption or avulsed cord) or bleeding from placenta previa.
  • Monochorionic twins or any higher order multiple pregnancy
  • Major fetal congenital or chromosomal abnormality
  • Documented fetal anemia or in utero red blood cell transfusion
  • Intent to withhold or withdraw treatment of the infant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Related Publications (1)

  • El-Naggar W, Mitra S, Abeysekera J, Disher T, Woolcott C, Hatfield T, McMillan D, Dorling J. Milking of the Cut Cord During Stabilization of Infants Born Very Premature: A Randomized Controlled Trial. J Pediatr. 2025 Mar;278:114444. doi: 10.1016/j.jpeds.2024.114444. Epub 2024 Dec 24.

    PMID: 39722339DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Walid El-Naggar

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walid El-Naggar, MD

CONTACT

902-470-7961walid.el-naggar@iwk.nshealth.ca

Jon Dorling, MD

CONTACT

902-470-6643Jon.Dorling@iwk.nshealth.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, Associate Professor of Pediatrics

Study Record Dates

First Submitted

April 30, 2018

First Posted

February 25, 2019

Study Start

February 7, 2019

Primary Completion

February 7, 2021

Study Completion

July 31, 2023

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations

CA(1)