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

Lund University

Status: Active, not recruiting

Conditions: Asphyxia Neonatorum; Resuscitation

Treatments: Procedure: Intact cord (≥ 180 seconds) resuscitation; Procedure: Early (≤ 60 seconds) cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT04070560

SAVE1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 35 to 42 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

Early (≤ 60 seconds) cord clamping

Active Comparator group

Description:

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

Treatment:

Procedure: Early (≤ 60 seconds) cord clamping

Intact cord (≥ 180 seconds) resuscitation

Active Comparator group

Description:

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

Treatment:

Procedure: Intact cord (≥ 180 seconds) resuscitation