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

Not Applicable

• Conditions: Preterm Infant
• Interventions: Procedure: MOCC Group; Procedure: DCC Group

• Registration Number: NCT03852134
• Lead Sponsor: IWK Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-30
• Status Verified: 2019-02
• Study Start: 2019-02-07
• Study First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Study First Posted: 2019-02-25
• Last Update Posted: 2019-02-25
• Primary Completion: 2021-02-07
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOCC Group	MOCC Group	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.
DCC group	DCC Group	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.

Primary Outcome Measures

Name	Time	Method
Number of adverse events associated with the MOCC intervention	Till the participants reach 2 year- corrected age (around 4.5 years)	To investigate any adverse events that could be attributed to the MOCC intervention.
Rate of compliance to the study intervention	Two years	to investigate the adherence to the new approach of MOCC during resuscitation/ stabilization following 30 seconds of DCC in preterm infants.
Number of patients completing the study	Two years	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.

Secondary Outcome Measures

Name	Time	Method
Compare hemoglobin (Hgb) concentration	From date of randomization and assessed up to 24 hours of age	to compare hemoglobin (Hgb) concentration on NICU admission in preterm infants \<32 weeks' gestation who receive MOCC during resuscitation/stabilization following 30 seconds of DCC with those who receive DCC alone for 30-60 seconds at birth (standard practice-control group).

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada