- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03852134
Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study) (MOCC)
Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Walid El-Naggar, MD
- Phone Number: 902-470-7961
- Email: walid.el-naggar@iwk.nshealth.ca
Study Contact Backup
- Name: Jon Dorling, MD
- Phone Number: 902-470-6643
- Email: Jon.Dorling@iwk.nshealth.ca
Study Locations
-
-
Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- Recruiting
- IWK Health Centre
-
Contact:
- Walid El-Naggar, MD
- Phone Number: 902-470-7961
- Email: walid.el-naggar@iwk.nshealth.ca
-
Contact:
- Jon Dorling, MD
- Phone Number: 902-470-6643
- Email: Jon.Dorling@iwk.nshealth.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
|
Active Comparator: 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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of compliance to the study intervention
Time Frame: Two years
|
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
Time Frame: 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.
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Two years
|
Number of adverse events associated with the MOCC intervention
Time Frame: 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.
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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
Time Frame: 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).
|
From date of randomization and assessed up to 24 hours of age
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temperature stability
Time Frame: From randomization assessed up to 2 hours of age
|
Temperature on admission to NICU
|
From randomization assessed up to 2 hours of age
|
Need for advanced resuscitation at birth
Time Frame: From randomization assessed up to 2 hours of age
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Need for advanced resuscitation including intubation, chest compressions and/or medications
|
From randomization assessed up to 2 hours of age
|
Inotropic support
Time Frame: From randomization assessed up to 72 hours of age
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Need for inotropic medication support
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From randomization assessed up to 72 hours of age
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Volume expander
Time Frame: From randomization assessed up to 72 hours of age
|
Assess the need for a volume expander (saline bolus or albumin bolus)
|
From randomization assessed up to 72 hours of age
|
Cerebral oxygenation
Time Frame: From randomization assessed up to 72 hours of age
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Measure the cerebral oxygenation using NIRS
|
From randomization assessed up to 72 hours of age
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Blood transfusion
Time Frame: From randomization assessed up to 36 weeks corrected gestational age
|
Assess the number of blood transfusions baby received from birth
|
From randomization assessed up to 36 weeks corrected gestational age
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Intraventricular hemorrhage (IVH)
Time Frame: From randomization assessed up to 36 weeks corrected age
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Assess the grade of IVH
|
From randomization assessed up to 36 weeks corrected age
|
Long-term outcomes
Time Frame: 24 Months Corrected age
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Long-term neurodevelopmental outcomes at 18-24 months of corrected age.
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24 Months Corrected age
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Walid El-Naggar, IWK Health Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOCC Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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