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

Study Overview
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Brief Summary
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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.

Official Title
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Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)

Conditions
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Preterm Infant

Intervention / Treatment
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* Procedure: MOCC Group
* Procedure: DCC Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Minute

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOCC Group<br>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<br>* 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.<br>* Other names: Monitoring cerebral oxygenation by NIRS;|
| Active Comparator: DCC group<br>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<br>* 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.<br>* Other names: Monitoring cerebral oxygenation by NIRS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare hemoglobin (Hgb) concentration | 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). | From date of randomization and assessed up to 24 hours of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infant, delayed cord clamping, cord milking, resuscitation