Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study)

IWK Health Centre

Status: Unknown

Conditions: Preterm Infant

Treatments: Procedure: DCC Group; Procedure: MOCC Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03852134

MOCC Study

Details and patient eligibility

About

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.

Enrollment: 98 estimated patients

Sex: All

Ages: Under 1 minute old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants <32 weeks' gestation

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

MOCC Group

Experimental group

Description:

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.

Treatment:

Procedure: MOCC Group

DCC group

Active Comparator group

Description:

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.

Treatment:

Procedure: DCC Group