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

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ClinicalTrials.gov Identifier: NCT03852134
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Walid El-Naggar, 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.

Condition or disease Intervention/treatment Phase
Preterm Infant Procedure: MOCC Group Procedure: DCC Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)
Actual Study Start Date : February 7, 2019
Estimated Primary Completion Date : February 7, 2021
Estimated Study Completion Date : July 31, 2023

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.
Procedure: MOCC Group
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 Name: Monitoring cerebral oxygenation by NIRS

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.

Procedure: 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.

Other Name: Monitoring cerebral oxygenation by NIRS




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. Temperature stability [ Time Frame: From randomization assessed up to 2 hours of age ]
    Temperature on admission to NICU

  2. Need for advanced resuscitation at birth [ Time Frame: From randomization assessed up to 2 hours of age ]
    Need for advanced resuscitation including intubation, chest compressions and/or medications

  3. Inotropic support [ Time Frame: From randomization assessed up to 72 hours of age ]
    Need for inotropic medication support

  4. 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)

  5. Cerebral oxygenation [ Time Frame: From randomization assessed up to 72 hours of age ]
    Measure the cerebral oxygenation using NIRS

  6. Blood transfusion [ Time Frame: From randomization assessed up to 36 weeks corrected gestational age ]
    Assess the number of blood transfusions baby received from birth

  7. Intraventricular hemorrhage (IVH) [ Time Frame: From randomization assessed up to 36 weeks corrected age ]
    Assess the grade of IVH

  8. Long-term outcomes [ Time Frame: 24 Months Corrected age ]
    Long-term neurodevelopmental outcomes at 18-24 months of corrected age.



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Ages Eligible for Study:   up to 1 Minute   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852134


Contacts
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Contact: Walid El-Naggar, MD 902-470-7961 walid.el-naggar@iwk.nshealth.ca
Contact: Jon Dorling, MD 902-470-6643 Jon.Dorling@iwk.nshealth.ca

Locations
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Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Walid El-Naggar, MD    902-470-7961    walid.el-naggar@iwk.nshealth.ca   
Contact: Jon Dorling, MD    902-470-6643    Jon.Dorling@iwk.nshealth.ca   
Sponsors and Collaborators
IWK Health Centre
Investigators
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Principal Investigator: Walid El-Naggar IWK Health Centre

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Responsible Party: Walid El-Naggar, Principle Investigator, Associate Professor of Pediatrics, IWK Health Centre
ClinicalTrials.gov Identifier: NCT03852134     History of Changes
Other Study ID Numbers: MOCC Study
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Walid El-Naggar, IWK Health Centre:
preterm infant
delayed cord clamping
cord milking
resuscitation

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications