Preterm Infant Clinical Trial
— Cord-milkingOfficial 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
Verified date | March 2024 |
Source | Jubilee Mission Medical College and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 250 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Minute to 5 Minutes |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | Jubilee Mission Medical College & Research Institute | Thrissur | Kerala |
Lead Sponsor | Collaborator |
---|---|
Jubilee Mission Medical College and Research Institute |
India,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Haemoglobin levels at birth | Haemoglobin levels at birth | 1 hour | |
Primary | 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 | The resuscitation interventions required with and without umbilical cord milking. | 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 | |
Secondary | Resuscitation outcomes with and without umbilical cord milking. | 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 | |
Secondary | Incidence of hypotension | Incidence of hypotension | 24 hours of life | |
Secondary | Requirement of inotropic support | Number of inotropes required for support | 24 hours of life | |
Secondary | symptomatic polycythemia | The number of neonates with symptomatic polycythemia (defined as lethargy, plethora, jitteriness, tachycardia, tachypnea and with venous hematocrit > 65%). | 48 hours of life | |
Secondary | Sepsis (culture positive) | Incidence of Sepsis (culture positive) | 72 hours of life | |
Secondary | Peak bilirubin levels | Serum peak bilirubin levels | 72 hours of life | |
Secondary | Requirement of phototherapy or exchange transfusion | 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 | |
Secondary | Incidence of Necrotising Enterocolitis (NEC) | Incidence of Necrotising Enterocolitis as defined by modified Bell's Criteria | 14 days of life | |
Secondary | Requirement of Oxygen | Requirement of Oxygen at 28 days of life and at 36 weeks gestation | 36 weeks of gestational age | |
Secondary | Requirement of red blood cell transfusions | Requirement of red blood cell transfusions before discharge | 4 weeks of life | |
Secondary | Number of days of Hospital Stay after Birth | Number of days of Hospital Stay after Birth | 4 weeks of life | |
Secondary | Death prior to discharge | Death prior to discharge | 4 weeks of life | |
Secondary | Serum iron stores | Serum iron stores (ferritin levels) at 6 weeks and 6 months of age | 6 months of age | |
Secondary | Developmental Assessment Scales for Indian Infants (DASII) | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04062513 -
Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
|
N/A | |
Completed |
NCT03412578 -
Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants
|
N/A | |
Completed |
NCT03166722 -
Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition
|
N/A | |
Enrolling by invitation |
NCT03212547 -
The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal.
|
N/A | |
Completed |
NCT03931902 -
The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates
|
N/A | |
Completed |
NCT03302000 -
Visual Stimulation of Preterm Infants
|
N/A | |
Completed |
NCT03731546 -
Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
|
N/A | |
Completed |
NCT03104946 -
To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants
|
N/A | |
Completed |
NCT03704012 -
Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
|
N/A | |
Suspended |
NCT03220282 -
The Milk, Growth and Microbiota Study
|
N/A | |
Active, not recruiting |
NCT03232931 -
Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
|
N/A | |
Completed |
NCT03242057 -
Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
|
N/A | |
Completed |
NCT04089540 -
New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates
|
N/A | |
Not yet recruiting |
NCT02528851 -
Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High EAP in Preterm Infants
|
N/A | |
Completed |
NCT01959737 -
Delivery Room Skin-to-skin Study
|
N/A | |
Completed |
NCT03700463 -
Executive Functions and Preterm Children in 3 to 4 Year Old
|
||
Completed |
NCT02811432 -
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
|
N/A | |
Completed |
NCT03728764 -
Growth and Safety of a Two-stage Feeding System in Preterm Infants
|
N/A | |
Completed |
NCT04382976 -
The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants
|
||
Completed |
NCT03748914 -
C-UCM and Cerebral Oxygenation and Perfusion
|
N/A |