- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03200301
Effect of Intact Umbilical Cord Milking on Neonatal and First Year Neurodevelopmental Outcomes in Very Preterm Infants. (Cord-milking)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Varghese PR, Ph D
- Phone Number: +919349151985
- Email: drprvarghese@gmail.com
Study Contact Backup
- Name: Manoj Varanattu, MD
- Phone Number: +919388407588
- Email: manojvaranattu@gmail.com
Study Locations
-
-
Kerala
-
Thrissur, Kerala, India, 680005
- Jubilee Mission Medical College & Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
No Intervention: Early Cord Clamping
Umbilical cord will be clamped immediately after delivery and baby will be handed over to the neonatal team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Haemoglobin levels at birth
Time Frame: 1 hour
|
Haemoglobin levels at birth
|
1 hour
|
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
|
7 days of life
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
20 minutes after delivery
|
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 |
20 minutes after delivery
|
Incidence of hypotension
Time Frame: 24 hours of life
|
Incidence of hypotension
|
24 hours of life
|
Requirement of inotropic support
Time Frame: 24 hours of life
|
Number of inotropes required for support
|
24 hours of life
|
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%).
|
48 hours of life
|
Sepsis (culture positive)
Time Frame: 72 hours of life
|
Incidence of Sepsis (culture positive)
|
72 hours of life
|
Peak bilirubin levels
Time Frame: 72 hours of life
|
Serum peak bilirubin levels
|
72 hours of life
|
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.
|
72 hours of life
|
Incidence of Necrotising Enterocolitis (NEC)
Time Frame: 14 days of life
|
Incidence of Necrotising Enterocolitis as defined by modified Bell's Criteria
|
14 days of life
|
Requirement of Oxygen
Time Frame: 36 weeks of gestational age
|
Requirement of Oxygen at 28 days of life and at 36 weeks gestation
|
36 weeks of gestational age
|
Requirement of red blood cell transfusions
Time Frame: 4 weeks of life
|
Requirement of red blood cell transfusions before discharge
|
4 weeks of life
|
Number of days of Hospital Stay after Birth
Time Frame: 4 weeks of life
|
Number of days of Hospital Stay after Birth
|
4 weeks of life
|
Death prior to discharge
Time Frame: 4 weeks of life
|
Death prior to discharge
|
4 weeks of life
|
Serum iron stores
Time Frame: 6 months of age
|
Serum iron stores (ferritin levels) at 6 weeks and 6 months of age
|
6 months of age
|
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)
|
1 year of corrected age
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Jubilee MMCRI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Preterm Infant
-
Duke UniversityNational Institute of Nursing Research (NINR)CompletedPreterm Infant Development | Preterm Infant Health
-
Christiana Care Health ServicesCompletedInfant | Infant, Premature | Infant, Preterm | Infant, LateUnited States
-
Medical University of GrazCompleted
-
NICHD Neonatal Research NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedInfant, Newborn | Infant, Moderate PretermUnited States
-
NICHD Neonatal Research NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedInfant, Newborn | Infant, Moderate PretermUnited States
-
University of OxfordShoklo Malaria Research UnitCompleted
-
yangjieCompletedOutcome, Fatal | Preterm Infant | Morbidity;Infant
-
Medical University of GrazCompletedIntubation; Difficult or Failed | Preterm Infant | Term InfantAustria
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedPreterm Birth | Cerebral Autoregulation | Premature Infant DiseaseItaly
-
Nantes University HospitalCompleted
Clinical Trials on Intact Umbilical Cord Milking
-
Marwa Mohamed FaragCompleted
-
Eastern Virginia Medical SchoolCompletedPrematurityUnited States
-
University of FlorenceActive, not recruiting
-
Thomas Jefferson UniversityLata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur...CompletedHypoxic Ischemic Encephalopathy | Umbilical Cord MilkingIndia
-
Xinhua Hospital, Shanghai Jiao Tong University...Shanghai First Maternity and Infant Hospital; Yangpu District Central Hospital...Completed
-
Nemours Children's ClinicEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingHypoxic-Ischemic Encephalopathy | Birth AsphyxiaIndia
-
Nemours Children's ClinicSharp HealthCare; NPKSIMS, Nagpur, IndiaWithdrawnHypoxic-Ischemic Encephalopathy | Birth AsphyxiaIndia
-
Mansoura University Children HospitalCompletedPreterm Infant | Placental InsufficiencyEgypt
-
King Abdulaziz UniversityRecruitingIntraventricular Hemorrhage | PreTerm BirthSaudi Arabia
-
Jubilee Mission Medical College and Research InstituteUnknownHypoxic-Ischemic EncephalopathyIndia