Back to resultsMilking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study) (MOCC)
Primary Purpose
Preterm Infant
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MOCC Group
DCC Group
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Infant focused on measuring preterm infant, delayed cord clamping, cord milking, resuscitation
Eligibility Criteria
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
Sites / Locations
- IWK Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MOCC Group
DCC group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Number of adverse events associated with the MOCC intervention
To investigate any adverse events that could be attributed to the MOCC intervention.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03852134
Brief Title
Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study)
Acronym
MOCC
Official Title
Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
February 7, 2021 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant
Keywords
preterm infant, delayed cord clamping, cord milking, resuscitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MOCC Group
Arm Type
Experimental
Arm 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.
Arm Title
DCC group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
MOCC Group
Other Intervention Name(s)
Monitoring cerebral oxygenation by NIRS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
DCC Group
Other Intervention Name(s)
Monitoring cerebral oxygenation by NIRS
Intervention 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.
Primary Outcome Measure Information:
Title
Rate of compliance to the study intervention
Description
to investigate the adherence to the new approach of MOCC during resuscitation/ stabilization following 30 seconds of DCC in preterm infants.
Time Frame
Two years
Title
Number of patients completing the study
Description
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.
Time Frame
Two years
Title
Number of adverse events associated with the MOCC intervention
Description
To investigate any adverse events that could be attributed to the MOCC intervention.
Time Frame
Till the participants reach 2 year- corrected age (around 4.5 years)
Secondary Outcome Measure Information:
Title
Compare hemoglobin (Hgb) concentration
Description
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).
Time Frame
From date of randomization and assessed up to 24 hours of age
Other Pre-specified Outcome Measures:
Title
Temperature stability
Description
Temperature on admission to NICU
Time Frame
From randomization assessed up to 2 hours of age
Title
Need for advanced resuscitation at birth
Description
Need for advanced resuscitation including intubation, chest compressions and/or medications
Time Frame
From randomization assessed up to 2 hours of age
Title
Inotropic support
Description
Need for inotropic medication support
Time Frame
From randomization assessed up to 72 hours of age
Title
Volume expander
Description
Assess the need for a volume expander (saline bolus or albumin bolus)
Time Frame
From randomization assessed up to 72 hours of age
Title
Cerebral oxygenation
Description
Measure the cerebral oxygenation using NIRS
Time Frame
From randomization assessed up to 72 hours of age
Title
Blood transfusion
Description
Assess the number of blood transfusions baby received from birth
Time Frame
From randomization assessed up to 36 weeks corrected gestational age
Title
Intraventricular hemorrhage (IVH)
Description
Assess the grade of IVH
Time Frame
From randomization assessed up to 36 weeks corrected age
Title
Long-term outcomes
Description
Long-term neurodevelopmental outcomes at 18-24 months of corrected age.
Time Frame
24 Months Corrected age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Minute
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walid El-Naggar, MD
Phone
902-470-7961
Email
walid.el-naggar@iwk.nshealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jon Dorling, MD
Phone
902-470-6643
Email
Jon.Dorling@iwk.nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid El-Naggar
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walid El-Naggar, MD
Phone
902-470-7961
Email
walid.el-naggar@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Jon Dorling, MD
Phone
902-470-6643
Email
Jon.Dorling@iwk.nshealth.ca
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared
Learn more about this trial
Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study)
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