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Effect of Intact Umbilical Cord Milking on Neonatal and First Year Neurodevelopmental Outcomes in Very Preterm Infants. (Cord Milking)

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ClinicalTrials.gov Identifier: NCT03200301
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jubilee Mission Medical College and Research Institute

Brief Summary:
The investigators hypothesise that intact umbilical cord milking (I-UCM) will reduce neonatal morbidity and improve long term neurodevelopmental outcome in very preterm infants. All babies born less than 32 weeks gestation, meeting the inclusion criteria will be randomly assigned to either I-UCM or immediate cord clamping (ICC) and their short and long term outcome measures analyzed.

Condition or disease Intervention/treatment Phase
Preterm Infant Umbilical Cord Milking Procedure: Intact Umbilical Cord Milking Not Applicable

Detailed Description:

Optimizing placental transfusion at birth promotes a more physiologic transition from intrauterine to extrauterine life. There is increasing evidence about the benefits of enhanced placental transfusion in improving neonatal outcomes, such as higher hemoglobin concentration, improved hemodynamic stability, reduced incidence of intraventricular hemorrhage, less need for blood transfusions and better neurodevelopmental outcome in preterm infants.

The investigators propose to evaluate the the safety and effectiveness of I-UCM versus ICC in mothers undergoing preterm delivery before 32 weeks, by randomly assigning them to one of two groups - study and control. The study group will undergo I-UCM during delivery and the control group will have ICC, which is the current standard of care. Both groups will subsequently receive routine care for mother and infant. In the study group the infants will be placed at or ∼20 cm below the level of the placenta and about 20 cm of the intact umbilical cord will be milked towards the umbilicus three times. The technique consists of pinching the cord close to the placenta and milking about 20 cm segment of the cord proximal to the umbilicus, towards the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 2-second pause between each milking motion. After completion of milking three times, the cord will be clamped close to the umbilicus and the neonate handed over to the neonatal team. The procedure of cord milking will be completed within 20 seconds.

Prenatal and delivery data will be collected from the mother's charts. Infant data will be collected from hospital admission records and from follow up for a period up to 12 months of corrected age. The infant data collected will include hemoglobin levels at birth, incidence and severity of intraventricular hemorrhage in the first week of life and neonatal morbidity (resuscitation measures, peak bilirubin, need for phototherapy and blood transfusion, sepsis, necrotizing enterocolitis, retinopathy of prematurity and chronic lung disease) and mortality. The neurodevelopmental status of both the study and control group of infants will be assessed at 6 months and one year of corrected age. The investigators hypothesize that I-UCM provides a greater placental transfusion and better neonatal outcomes when compared to ICC. It is a simple procedure which can be practiced universally and of great relevance to both developed and developing countries.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intact Umbilical Cord Milking Versus Immediate Cord Clamping on Neonatal Outcomes and First Year Neurodevelopmental Outcomes in Very Preterm Infants - A Randomised Controlled Trial
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Intact Umbilical Cord Milking
Umbilical Cord Milking involves pinching of the cord close to the placenta and milking about 20 cm segment of the cord proximal to the umbilicus, towards the infant over a 2-second duration. The cord will be then released, allowing for a brief 2-second pause between each milking motion. This will be repeated for a total of 3 times over a duration less than 20 seconds.
Procedure: Intact Umbilical Cord Milking
Immediately after delivery, the infant will be placed at or ∼20 cm below the level of the placenta and about 20 cm of the intact umbilical cord will be milked towards the umbilicus three times. The technique consists of pinching the cord close to the placenta and milking about 20 cm segment of the cord proximal to the umbilicus, towards the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 2-second pause between each milking motion. After completion of milking three times, the cord will be clamped close to the umbilicus and the neonate handed over to the neonatal team. The procedure of cord milking will be completed within 20 seconds.
Other Name: Milking of the Umbilical Cord

No Intervention: Early Cord Clamping
Umbilical cord will be clamped immediately after delivery and baby will be handed over to the neonatal team.



Primary Outcome Measures :
  1. Haemoglobin levels at birth [ Time Frame: 1 hour ]
    Haemoglobin levels at birth

  2. Intraventricular Haemorrhage [ Time Frame: 7 days of life ]
    Incidence and severity of Intraventricular Haemorrhage in the first week of life - Cranial Ultrasound done on day 7


Secondary Outcome Measures :
  1. The resuscitation interventions required with and without umbilical cord milking. [ Time Frame: 20 minutes after delivery ]
    The resuscitation interventions required that will be assessed are requirement of Continuous Positive Airway Pressure (CPAP), oxygen, mask and bag ventilation, endotracheal intubation and ventilation, chest compressions, drugs, and fluid boluses

  2. Resuscitation outcomes with and without umbilical cord milking. [ Time Frame: 20 minutes after delivery ]

    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.

    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


  3. Incidence of hypotension [ Time Frame: 24 hours of life ]
    Incidence of hypotension

  4. Requirement of inotropic support [ Time Frame: 24 hours of life ]
    Number of inotropes required for support

  5. symptomatic polycythemia [ Time Frame: 48 hours of life ]
    The number of neonates with symptomatic polycythemia (defined as lethargy, plethora, jitteriness, tachycardia, tachypnea and with venous hematocrit > 65%).

  6. Sepsis (culture positive) [ Time Frame: 72 hours of life ]
    Incidence of Sepsis (culture positive)

  7. Peak bilirubin levels [ Time Frame: 72 hours of life ]
    Serum peak bilirubin levels

  8. Requirement of phototherapy or exchange transfusion [ Time Frame: 72 hours of life ]
    Neonates requiring phototherapy or exchange transfusion will be evaluated according to the NICE 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.

  9. Incidence of Necrotising Enterocolitis (NEC) [ Time Frame: 14 days of life ]
    Incidence of Necrotising Enterocolitis as defined by modified Bell's Criteria

  10. Requirement of Oxygen [ Time Frame: 36 weeks of gestational age ]
    Requirement of Oxygen at 28 days of life and at 36 weeks gestation

  11. Requirement of red blood cell transfusions [ Time Frame: 4 weeks of life ]
    Requirement of red blood cell transfusions before discharge

  12. Number of days of Hospital Stay after Birth [ Time Frame: 4 weeks of life ]
    Number of days of Hospital Stay after Birth

  13. Death prior to discharge [ Time Frame: 4 weeks of life ]
    Death prior to discharge

  14. Serum iron stores [ Time Frame: 6 months of age ]
    Serum iron stores (ferritin levels) at 6 weeks and 6 months of age

  15. Developmental Assessment Scales for Indian Infants (DASII) [ Time Frame: 1 year of corrected age ]
    Developmental Assessment Scales for Indian Infants (DASII) tests carried out at 6 months and 1 year of corrected age. The DASII scale is divided into motor scale and mental scale. The motor scale consists of 67 items and mental scale consists of 163 items. (P Phatak, et al, 1996)



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Ages Eligible for Study:   up to 5 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All the preterm infants of less than 32 weeks of gestation born of consenting parents in the hospital

Exclusion Criteria:

  • Neonates depressed at birth, MCMA, MCDA Twin pregnancy (DCDA twins are included), Severe IUGR in antenatal scans (< 10th Centile), Known case of Hydrops fetalis, Known major congenital anomaly, Placenta previa and abruptions, bleeding, accreta, nuchal cord, anhydramnios, PROM > 2 weeks before 24 weeks and Refusal to Consent by the Parents

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): NCT03200301


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

Locations
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India
Jubilee Mission Medical College & Research Institute Recruiting
Thrissur, Kerala, India, 680005
Contact: Manoj varanattu    9388407588    manojvaranattu@gmail.com   
Contact: manoj varanattu    7012225043    manojvaranattu@gmail.com   
Sponsors and Collaborators
Jubilee Mission Medical College and Research Institute
Publications:

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Responsible Party: Jubilee Mission Medical College and Research Institute
ClinicalTrials.gov Identifier: NCT03200301    
Other Study ID Numbers: Jubilee MMCRI
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications