Clinical trial NCT03200301: Effect of Intact Umbilical Cord Milking on Neonatal and First Year Neurodevelopmental Outcomes in Very Preterm Infants.
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preterm Infant
Umbilical Cord Milking
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Haemoglobin levels at birth
timeFrame: 1 hour
measure: Intraventricular Haemorrhage
timeFrame: 7 days of life
Secondary outcomes:
measure: The resuscitation interventions required with and without umbilical cord milking.
timeFrame: 20 minutes after delivery
measure: Resuscitation outcomes with and without umbilical cord milking.
timeFrame: 20 minutes after delivery
measure: Incidence of hypotension
timeFrame: 24 hours of life
measure: Requirement of inotropic support
timeFrame: 24 hours of life
measure: symptomatic polycythemia
timeFrame: 48 hours of life
measure: Sepsis (culture positive)
timeFrame: 72 hours of life
measure: Peak bilirubin levels
timeFrame: 72 hours of life
measure: Requirement of phototherapy or exchange transfusion
timeFrame: 72 hours of life
measure: Incidence of Necrotising Enterocolitis (NEC)
timeFrame: 14 days of life
measure: Requirement of Oxygen
timeFrame: 36 weeks of gestational age
measure: Requirement of red blood cell transfusions
timeFrame: 4 weeks of life
measure: Number of days of Hospital Stay after Birth
timeFrame: 4 weeks of life
measure: Death prior to discharge
timeFrame: 4 weeks of life
measure: Serum iron stores
timeFrame: 6 months of age
measure: Developmental Assessment Scales for Indian Infants (DASII)
timeFrame: 1 year of corrected age
Other outcomes:
Locations:
city: Thrissur
country: India
facility: Jubilee Mission Medical College & Research Institute
state: Kerala
Study officials:
References:
citation: 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.
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