Preterm InfantCord-milkingNCT03200301
Effect of Intact Umbilical Cord Milking on Neonatal and First Year Neurodevelopmental Outcomes in Very Preterm Infants.
A study testing Intact Umbilical Cord Milking in people with Preterm Infant and Umbilical Cord Milking, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 minute to 5 minutesHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant, Umbilical Cord Milking
- What is being tested?
- Intact Umbilical Cord Milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2018to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 5 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All the preterm infants of less than 32 weeks of gestation born of consenting parents in the hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Jubilee Mission Medical College & Research Institute
Thrissur, Kerala, 680005
About this study
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
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.
Read the 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.
- Conditions
- Preterm Infant, Umbilical Cord Milking
- Being tested
- Intact Umbilical Cord Milking
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intact Umbilical Cord MilkingProcedure or surgery
Also called Milking of the Umbilical Cord
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin levels at birth
Haemoglobin levels at birth
Measured: 1 hour
Intraventricular Haemorrhage
Incidence and severity of Intraventricular Haemorrhage in the first week of life - Cranial Ultrasound done on day 7
Measured: 7 days of life
Secondary outcomes (15)
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
Measured: 20 minutes after delivery
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
Measured: 20 minutes after delivery
Incidence of hypotension
Incidence of hypotension
Measured: 24 hours of life
Requirement of inotropic support
Number of inotropes required for support
Measured: 24 hours of life
symptomatic polycythemia
The number of neonates with symptomatic polycythemia (defined as lethargy, plethora, jitteriness, tachycardia, tachypnea and with venous hematocrit > 65%).
Measured: 48 hours of life
Sepsis (culture positive)
Incidence of Sepsis (culture positive)
Measured: 72 hours of life
Peak bilirubin levels
Serum peak bilirubin levels
Measured: 72 hours of life
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.
Measured: 72 hours of life
Incidence of Necrotising Enterocolitis (NEC)
Incidence of Necrotising Enterocolitis as defined by modified Bell's Criteria
Measured: 14 days of life
Requirement of Oxygen
Requirement of Oxygen at 28 days of life and at 36 weeks gestation
Measured: 36 weeks of gestational age
Requirement of red blood cell transfusions
Requirement of red blood cell transfusions before discharge
Measured: 4 weeks of life
Number of days of Hospital Stay after Birth
Number of days of Hospital Stay after Birth
Measured: 4 weeks of life
Death prior to discharge
Death prior to discharge
Measured: 4 weeks of life
Serum iron stores
Serum iron stores (ferritin levels) at 6 weeks and 6 months of age
Measured: 6 months of age
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)
Measured: 1 year of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Apr 2018
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200301
- Sponsor's protocol ID
- Jubilee MMCRI
- Acronym
- Cord-milking
- Status last verified
- Mar 2024
- First submitted
- 22 Jun 2017
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25365246Boere 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.
PubMed 25389141Katheria 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.
PubMed 28180126Katheria 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.
PubMed 26122803Rabe 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.
PubMed 26650133Ghavam 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.
PubMed 24843886Niermeyer 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.
PubMed 27057338Nolan 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.
PubMed 26477703Rabe 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.
PubMed 22895933Safarulla 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.
PubMed 27936996Committee 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.
PubMed 23168790Wyckoff 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.
PubMed 26473001
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03200301
- Acronym / sponsor ID
- Cord-milking / Jubilee MMCRI
- Conditions
- Preterm Infant, Umbilical Cord Milking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intact Umbilical Cord Milking | Experimental | Procedure: Intact Umbilical Cord MilkingUmbilical 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. |
| Early Cord Clamping | No intervention | –Umbilical cord will be clamped immediately after delivery and baby will be handed over to the neonatal team. |
Who may qualify
- Ages
- 1 minute to 5 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All the preterm infants of less than 32 weeks of gestation born of consenting parents in the hospital
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intact Umbilical Cord MilkingAlso: Milking of the Umbilical CordImmediately 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. | Procedure or surgery | Intact Umbilical Cord Milking |
Primary outcome
Haemoglobin levels at birth
Time frame: 1 hour
Haemoglobin levels at birth
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
15 secondary outcomes
The resuscitation interventions required with and without umbilical cord milking.
Time frame: 20 minutes after delivery
Resuscitation outcomes with and without umbilical cord milking.
Time frame: 20 minutes after delivery
Incidence of hypotension
Time frame: 24 hours of life
Requirement of inotropic support
Time frame: 24 hours of life
symptomatic polycythemia
Time frame: 48 hours of life
Sepsis (culture positive)
Time frame: 72 hours of life
Peak bilirubin levels
Time frame: 72 hours of life
Requirement of phototherapy or exchange transfusion
Time frame: 72 hours of life
Incidence of Necrotising Enterocolitis (NEC)
Time frame: 14 days of life
Requirement of Oxygen
Time frame: 36 weeks of gestational age
Requirement of red blood cell transfusions
Time frame: 4 weeks of life
Number of days of Hospital Stay after Birth
Time frame: 4 weeks of life
Death prior to discharge
Time frame: 4 weeks of life
Serum iron stores
Time frame: 6 months of age
Developmental Assessment Scales for Indian Infants (DASII)
Time frame: 1 year of corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 25365246Al-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.
- Background: PubMed 25389141Boere 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.
- Background: PubMed 28180126Katheria 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.
- Background: PubMed 26122803Katheria 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.
- Background: PubMed 26650133Rabe 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.
- Background: PubMed 24843886Ghavam 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.
- Background: PubMed 27057338Niermeyer 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.
- Background: PubMed 26477703Nolan 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.
- Background: PubMed 22895933Rabe 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.
- Background: PubMed 27936996Safarulla 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.
- Background: PubMed 23168790Committee 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.
- Background: PubMed 26473001Wyckoff 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intact Umbilical Cord Milking in people with Preterm Infant and Umbilical Cord Milking, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin levels at birth (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03200301, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.