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

NCT03200301 | Active Not Recruiting DMC

• 1 other identifier: Jubilee MMCRI
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Umbilical Cord Milking

Outcome Measures

Primary Outcomes (2)

• Haemoglobin levels at birth

  Haemoglobin levels at birth

  1 hour

• Intraventricular Haemorrhage

  Incidence and severity of Intraventricular Haemorrhage in the first week of life - Cranial Ultrasound done on day 7

  7 days of life

Secondary Outcomes (15)

• The resuscitation interventions required with and without umbilical cord milking.

  20 minutes after delivery

• Resuscitation outcomes with and without umbilical cord milking.

  20 minutes after delivery

• Incidence of hypotension

  24 hours of life

• Requirement of inotropic support

  24 hours of life

• symptomatic polycythemia

  48 hours of life

Study Arms (2)

Intact Umbilical Cord Milking

EXPERIMENTAL

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

Early Cord Clamping

NO INTERVENTION

Umbilical cord will be clamped immediately after delivery and baby will be handed over to the neonatal team.

Interventions

Intact Umbilical Cord Milking PROCEDURE

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.

Also known as: Milking of the Umbilical Cord

Intact Umbilical Cord Milking

Eligibility Criteria

• Age: 1 Minute - 5 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead

Study Sites (1)

Jubilee Mission Medical College & Research Institute

Thrissur, Kerala, 680005, India

Location

Related Publications (12)

• Al-Wassia H, Shah PS. Efficacy and safety of umbilical cord milking at birth: a systematic review and meta-analysis. JAMA Pediatr. 2015 Jan;169(1):18-25. doi: 10.1001/jamapediatrics.2014.1906.

  PMID: 25365246 BACKGROUND

• Boere I, Roest AA, Wallace E, Ten Harkel AD, Haak MC, Morley CJ, Hooper SB, te Pas AB. Umbilical blood flow patterns directly after birth before delayed cord clamping. Arch Dis Child Fetal Neonatal Ed. 2015 Mar;100(2):F121-5. doi: 10.1136/archdischild-2014-307144. Epub 2014 Nov 11.

  PMID: 25389141 BACKGROUND

• Katheria AC, Brown MK, Rich W, Arnell K. Providing a Placental Transfusion in Newborns Who Need Resuscitation. Front Pediatr. 2017 Jan 25;5:1. doi: 10.3389/fped.2017.00001. eCollection 2017.

  PMID: 28180126 BACKGROUND

• Katheria AC, Truong G, Cousins L, Oshiro B, Finer NN. Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants. Pediatrics. 2015 Jul;136(1):61-9. doi: 10.1542/peds.2015-0368.

  PMID: 26122803 BACKGROUND

• Rabe H, Sawyer A, Amess P, Ayers S; Brighton Perinatal Study Group. Neurodevelopmental Outcomes at 2 and 3.5 Years for Very Preterm Babies Enrolled in a Randomized Trial of Milking the Umbilical Cord versus Delayed Cord Clamping. Neonatology. 2016;109(2):113-9. doi: 10.1159/000441891. Epub 2015 Dec 10.

  PMID: 26650133 BACKGROUND

• Ghavam S, Batra D, Mercer J, Kugelman A, Hosono S, Oh W, Rabe H, Kirpalani H. Effects of placental transfusion in extremely low birthweight infants: meta-analysis of long- and short-term outcomes. Transfusion. 2014 Apr;54(4):1192-8. doi: 10.1111/trf.12469.

  PMID: 24843886 BACKGROUND

• Niermeyer S. A physiologic approach to cord clamping: Clinical issues. Matern Health Neonatol Perinatol. 2015 Sep 8;1:21. doi: 10.1186/s40748-015-0022-5. eCollection 2015.

  PMID: 27057338 BACKGROUND

• Nolan JP, Hazinski MF, Aickin R, Bhanji F, Billi JE, Callaway CW, Castren M, de Caen AR, Ferrer JM, Finn JC, Gent LM, Griffin RE, Iverson S, Lang E, Lim SH, Maconochie IK, Montgomery WH, Morley PT, Nadkarni VM, Neumar RW, Nikolaou NI, Perkins GD, Perlman JM, Singletary EM, Soar J, Travers AH, Welsford M, Wyllie J, Zideman DA. Part 1: Executive summary: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2015 Oct;95:e1-31. doi: 10.1016/j.resuscitation.2015.07.039. No abstract available.

  PMID: 26477703 BACKGROUND

• Rabe H, Diaz-Rossello JL, Duley L, Dowswell T. Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD003248. doi: 10.1002/14651858.CD003248.pub3.

  PMID: 22895933 BACKGROUND

• Safarulla A. A review of benefits of cord milking over delayed cord clamping in the preterm infant and future directions of research. J Matern Fetal Neonatal Med. 2017 Dec;30(24):2966-2973. doi: 10.1080/14767058.2016.1269319. Epub 2017 Jan 12.

  PMID: 27936996 BACKGROUND

• Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.

  PMID: 23168790 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

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 27, 2017
• Study Start: April 1, 2018
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

IN (1)