Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and half will have their umbilical cord cut.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hemodynamic Effects of Delayed Umbilical Cord Clamping in Full-term Newborns

NCT04358822

Cardiac Output, High Cardiac Output, Low

COMPLETED NA

Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants

NCT01523769

Prematurity

COMPLETED NA

The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates.

NCT03147846

Delayed Cord Clamping Umbilical Cord Milking Preterm Neonates

COMPLETED NA

The Effect of Cord Milking on Hemodynamic Status of Preterm Infants

NCT01487187

Preterm Infants

UNKNOWN NA

Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation

NCT06090968

Hypoxic-Ischemic Encephalopathy Perinatal Asphyxia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The routine procedure when a newborn baby is in need of resuscitation is to cut the umbilical cord and move the baby to a designated area for resuscitation, which can include stimulation, clearing the airways, administration of oxygen and/or positive pressure ventilation by bag and mask och T-piece resuscitator.

It has been suggested, and pilot studies has shown preliminary results, that keeping the umbilical cord intact while performing resuscitation may improve the babies outcome, by continued exchange of oxygen and carbon dioxide be the placenta and facilitating the neonatal pulmonary and circulatory transition.

Because of the limiting length of the umbilical cord, resuscitation with an intact cord must be performed in close proximity to the mother.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asphyxia Neonatorum Resuscitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early (≤ 60 seconds) cord clamping

If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table Other Name: Immediate clamping

Group Type ACTIVE_COMPARATOR

Early (≤ 60 seconds) cord clamping

Intervention Type PROCEDURE

Resuscitation performed at a designated area after umbilical cord is cut

Intact cord (≥ 180 seconds) resuscitation

If the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother

Other Names:

Late cord clamping Deferred cord clamping Optimal cord clamping

Group Type ACTIVE_COMPARATOR

Intact cord (≥ 180 seconds) resuscitation

Intervention Type PROCEDURE

Resuscitation performed in near proximity to the mother with umbilical cord uncut

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intact cord (≥ 180 seconds) resuscitation

Resuscitation performed in near proximity to the mother with umbilical cord uncut

Intervention Type PROCEDURE

Early (≤ 60 seconds) cord clamping

Resuscitation performed at a designated area after umbilical cord is cut

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnancy week ≥35 + 0
* Singletons
* Expected vaginal delivery
* The woman / couple can adequately assimilate information about the study
* Signed informed consent of both prospective parents

Exclusion Criteria

* Congenital malformation that complicates resuscitation (such as severe malformation of mouth, pharynx, respiratory system) or which causes the child not to be resuscitated due to internal structural malformations (such as more severe heart failure, diaphragm fractures, etc.)
* The child is born via acute caesarean section after inclusion and opening of study envelope
* placenta abruption / or damage to umbilical cord during childbirth (when circulation through an intact umbilical cord cannot be achieved after birth)

Minimum Eligible Age

35 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No