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Role of Umbilical Cord Milking in the Management of Hypoxic-ischemic Encephalopathy in Neonates

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ClinicalTrials.gov Identifier: NCT03123081
Recruitment Status : Not yet recruiting
First Posted : April 21, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Manoj Varanattu, Jubilee Mission Medical College and Research Institute

Brief Summary:
The purpose of this study is to investigate the efficacy and safety of umbilical cord milking in depressed neonates at birth for prevention of hypoxic ischemic encephalopathy.

Condition or disease Intervention/treatment Phase
Hypoxic-Ischemic Encephalopathy Procedure: Umbilical Cord Milking Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Role of Umbilical Cord Milking in the Management of Hypoxic-ischemic Encephalopathy in Neonates: a Randomized Controlled Trial
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: Umbilical Cord Milking
Umbilical Cord Milking involves milking 30 cm length of cord at birth, after initiation of ventilation.
Procedure: Umbilical Cord Milking
At birth the cord of a depressed newborn is clamped immediately and cut 30 cm from the umbilicus. After completion of initial steps, if required, positive pressure ventilation (PPV) is given for 30 seconds, along with UCM. The cord is untwisted and held in a vertical position. It is milked 3 times towards the baby at a speed of 10 cm/s and then clamped 3 cm from the umbilicus. After completion of PPV along with UCM, if the baby requires further resuscitation, the NRP 2015 guidelines will be followed. Depressed newborns who respond to initial steps of resuscitation with normal breathing and heart rate of 100 bpm or higher, will receive UCM after this.
Other Names:
  • UCM
  • Umbilical cord stripping

No Intervention: Immediate Umbilical Cord Clamping
Procedure: No Intervention: Immediate Umbilical Cord Clamping or Immediate Cord Clamping.



Primary Outcome Measures :
  1. Incidence and severity of HIE in depressed neonates with and without umbilical cord milking [ Time Frame: 72 hours ]

    The severity of HIE if any will be assessed by modified Sarnat staging which is based on level of consciousness, spontaneous activity, neuromuscular control, primitive reflexes, autonomic function and seizures.

    [Designated as safety issue: No];

    Ref:Sarnat HB, Sarnat MS. Neonatal encephalopathy following fetal distress. A clinical and electroencephalographic study. Arch Neurol. 1976; 33:696-705. PMID: 987769



Secondary Outcome Measures :
  1. The resuscitation interventions required and the short term outcomes for depressed newborns with and without umbilical cord milking. [ Time Frame: 20 minutes after delivery ]

    The resuscitation interventions required (use of CPAP, oxygen, mask and bag ventilation, endotracheal intubation and ventilation, chest compressions, drugs, and fluid boluses) and the short term outcomes of resuscitation will be assessed using the validated Combined Apgar score (consisting of the Expanded and Specified Apgar scoring systems) introduced by Rudiger et al, in depressed neonates with and without UCM.

    [Designated as safety issue: No];

    Ref:Dalili H, Nili F, Sheikh M, Hardani AK, Shariat M, Nayeri F (2015) Comparison of the Four Proposed Apgar Scoring Systems in the Assessment of Birth Asphyxia and Adverse Early Neurologic Outcomes. PLoS ONE 10(3): e0122116


  2. Requirement of Neonatal Intensive Care Unit (NICU) admission [ Time Frame: 1st 24 hours after delivery ]
    Requirement of Neonatal Intensive Care Unit (NICU) admission [Designated as safety issue: No]

  3. Blood lactate at 24 hours [ Time Frame: 1st 24 hours after delivery ]

    Lactate in the peripheral blood at 24 hours after birth in neonates with any grade of HIE.

    [Designated as safety issue: No]


  4. CD34+ stem cell count at 24 hours [ Time Frame: 24 hours after birth ]

    CD34+ stem cell count in the peripheral blood at 24 hours after birth in neonates with any grade of HIE.

    [Designated as safety issue: No]


  5. The number of neonates with symptomatic polycythemia [ Time Frame: 48 hours after birth ]

    The number of neonates with symptomatic polycythemia defined as lethargy, plethora, jitteriness, tachycardia, tachypnea and with venous hematocrit > 65%.

    [Designated as safety issue: No];


  6. The number of neonates with hyperbilirubinemia requiring phototherapy or exchange transfusion. [ Time Frame: 72 hours after birth ]

    Neonates requiring phototherapy or exchange transfusion will be evaluated according to the NICE/AAP guidelines and serum bilirubin levels will be interpreted according to the baby's age in hours. Physicians who assess the neonate and advice phototherapy or exchange transfusion will be blinded to the intervention.

    [Designated as safety issue: No]


  7. The number of neonates with anemia [ Time Frame: 2 hours after birth ]
    The number of neonates with anemia defined as venous hemoglobin < 12.5 g/dL [Designated as safety issue: No];

  8. MRI changes in the brain of neonates with moderate and severe degrees of HIE who underwent whole body hypothermia. [ Time Frame: 14 days after birth ]

    MRI examination will be performed in neonates who underwent whole body hypothermia 7-14 days after birth and the changes in brain scored as per a validated MR scoring system (Barkovich et al, Am J Neuroradiol 1998;19:143-9) by a neuroradiologist blinded to the intervention.

    [Designated as safety issue: No];

    Ref:Barkovich AJ, Hajnal BL, Vigneron D, Sola A, Partridge JC, Allen F, et al. Prediction of neuromotor outcome in perinatal asphyxia: evaluation of MR scoring systems. Am J Neuroradiol 1998;19:143-9. [PubMed: 9432172]


  9. Duration of hospital stay in neonates with any grade of HIE. [ Time Frame: Duration of hospital stay, an expected average of 7-14 days ]
    Duration of hospital stay in neonates with any grade of HIE. [Designated as safety issue: No]

  10. Survival at 6 weeks of age [ Time Frame: 6 weeks after birth ]
    Survival at 6 weeks of age [Designated as safety issue: No]

  11. Haemoglobin levels at 6 weeks of age [ Time Frame: 6 weeks after birth ]
    Haemoglobin levels at 6 weeks of age [Designated as safety issue: No]

  12. Serum ferritin levels at 6 weeks of age [ Time Frame: 6 weeks after birth ]
    Serum ferritin levels at 6 weeks of age [Designated as safety issue: No]



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Ages Eligible for Study:   up to 24 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Neonates of ≥35 week's gestation and born depressed (defined by NRP 2015 criteria: as those neonates who doesn't cry or breathe at birth and whose tone is poor) in the hospital

Exclusion Criteria:

  • MCDA Twin pregnancy (DCDA twins are included)
  • Triplet or quadruplet pregnancy
  • Presence of IUGR in antenatal scans (< 10th Centile)
  • Short umbilical cord length (<30 cm)
  • Rh-negative or retrovirus positive mothers
  • Major chromosomal or congenital anomalies
  • Hydrops fetalis
  • Severe placental abruption
  • Cord prolapse and cord abnormalities such as true knots
  • Culture positive early onset neonatal sepsis

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): NCT03123081


Contacts
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Contact: Manoj Varanattu, M D +919388407588 manojvaranattu@gmail.com
Contact: Varghese PR, Ph D +919349151985 drprvarghese@gmail.com

Sponsors and Collaborators
Jubilee Mission Medical College and Research Institute
Investigators
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Principal Investigator: Manoj Varanattu, MD Jubilee Mission Medical College and Research Institute

Publications:
Hong Huang, Nicholas Eastman, Brandon Schanbacher et al. Impact of Delayed Cord Clamping on Circulating Progenitor Cells in Extremely Premature Infants. E-PAS 2016:3821.208

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Responsible Party: Dr. Manoj Varanattu, Professor, Department of Neonatology, Jubilee Mission Medical College and Research Institute
ClinicalTrials.gov Identifier: NCT03123081     History of Changes
Other Study ID Numbers: JubileeMMCRI
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Hypoxia
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain