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

NCT03123081 | Unknown DMC

• 1 other identifier: JubileeMMCRI
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic-Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of HIE in depressed neonates with and without umbilical cord milking

  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

  72 hours

Secondary Outcomes (12)

• The resuscitation interventions required and the short term outcomes for depressed newborns with and without umbilical cord milking.

  20 minutes after delivery

• Requirement of Neonatal Intensive Care Unit (NICU) admission

  1st 24 hours after delivery

• Blood lactate at 24 hours

  1st 24 hours after delivery

• CD34+ stem cell count at 24 hours

  24 hours after birth

• The number of neonates with symptomatic polycythemia

  48 hours after birth

Study Arms (2)

Umbilical Cord Milking

EXPERIMENTAL

Umbilical Cord Milking involves milking 30 cm length of cord at birth, after initiation of ventilation.

Procedure: Umbilical Cord Milking

Immediate Umbilical Cord Clamping

NO INTERVENTION

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

Interventions

Umbilical Cord Milking PROCEDURE

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.

Also known as: UCM, Umbilical cord stripping

Umbilical Cord Milking

Eligibility Criteria

• Age: 1 Minute - 24 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead

Study Sites (1)

Jubilee Mission Medical College & Research Institute

Thrissur, Kerala, 680006, India

RECRUITING

Related Publications (10)

• Upadhyay A, Gothwal S, Parihar R, Garg A, Gupta A, Chawla D, Gulati IK. Effect of umbilical cord milking in term and near term infants: randomized control trial. Am J Obstet Gynecol. 2013 Feb;208(2):120.e1-6. doi: 10.1016/j.ajog.2012.10.884. Epub 2012 Oct 31.

  PMID: 23123382 BACKGROUND

• Erickson-Owens DA, Mercer JS, Oh W. Umbilical cord milking in term infants delivered by cesarean section: a randomized controlled trial. J Perinatol. 2012 Aug;32(8):580-4. doi: 10.1038/jp.2011.159. Epub 2011 Nov 17.

  PMID: 22094494 BACKGROUND

• Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.

  PMID: 26473001 BACKGROUND

• Jaiswal P, Upadhyay A, Gothwal S, Singh D, Dubey K, Garg A, Vishnubhatala S. Comparison of two types of intervention to enhance placental redistribution in term infants: randomized control trial. Eur J Pediatr. 2015 Sep;174(9):1159-67. doi: 10.1007/s00431-015-2511-y. Epub 2015 Mar 24.

  PMID: 25800496 BACKGROUND

• Mercer JS, Erickson-Owens DA. Is it time to rethink cord management when resuscitation is needed? J Midwifery Womens Health. 2014 Nov-Dec;59(6):635-644. doi: 10.1111/jmwh.12206. Epub 2014 Oct 8.

  PMID: 25297530 BACKGROUND

• 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

  BACKGROUND

• Aridas JD, McDonald CA, Paton MC, Yawno T, Sutherland AE, Nitsos I, Pham Y, Ditchfield M, Fahey MC, Wong F, Malhotra A, Castillo-Melendez M, Bhakoo K, Wallace EM, Jenkin G, Miller SL. Cord blood mononuclear cells prevent neuronal apoptosis in response to perinatal asphyxia in the newborn lamb. J Physiol. 2016 Mar 1;594(5):1421-35. doi: 10.1113/JP271104. Epub 2015 Dec 14.

  PMID: 26527561 BACKGROUND

• Sarnat HB, Sarnat MS. Neonatal encephalopathy following fetal distress. A clinical and electroencephalographic study. Arch Neurol. 1976 Oct;33(10):696-705. doi: 10.1001/archneur.1976.00500100030012.

  PMID: 987769 BACKGROUND

• Dalili H, Nili F, Sheikh M, Hardani AK, Shariat M, Nayeri F. Comparison of the four proposed Apgar scoring systems in the assessment of birth asphyxia and adverse early neurologic outcomes. PLoS One. 2015 Mar 26;10(3):e0122116. doi: 10.1371/journal.pone.0122116. eCollection 2015.

  PMID: 25811904 BACKGROUND

• Barkovich AJ, Hajnal BL, Vigneron D, Sola A, Partridge JC, Allen F, Ferriero DM. Prediction of neuromotor outcome in perinatal asphyxia: evaluation of MR scoring systems. AJNR Am J Neuroradiol. 1998 Jan;19(1):143-9.

  PMID: 9432172 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Manoj Varanattu, MD

  Jubilee Mission Medical College and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manoj Varanattu, M D

CONTACT

+919388407588; manojvaranattu@gmail.com

Varghese PR, Ph D

CONTACT

+919349151985; drprvarghese@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind (Subject)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neonatology

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: April 21, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: July 1, 2022
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)