AnemiaNCT03023917
The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in Preterms
A study testing umbilical cord milking and umbilical cord clamping immediately in people with Anemia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The overall objective of the present study is to examine the effects of umbilical cord milking at birth in preterm infants to prevent and decrease anemia using a multi-center prospective randomized controlled trial comparing immediate cord clamping (standard at present) with umbilical cord milking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia
- What is being tested?
- umbilical cord milking and umbilical cord clamping immediately
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2017to 31 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women in labour or with a plan for delivery at a gestational age less than 34 weeks gestation.
- Singleton pregnancy
- informed consent was obtained from the parent
Who cannot join
- Multiple gestation
- Diagnosis of any of the following in the current pregnancy: hemorrhage requiring clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome of the fetus,anemia
- Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies
- Diagnosis at any time for the mother of any of the following: serious Diabetes, serious hypertension, chronic renal disease
- Infant with major congenital malformation
- Infant with blood disease
- Unwilling to return for follow-up study visits at the hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial
The overall objective of the present study is to examine the effects of umbilical cord milking at birth in preterm infants to prevent and decrease anemia using a multi-center prospective randomized controlled trial comparing immediate cord clamping (standard at present) with umbilical cord milking.
Read the detailed description
Anemia is a significant problem for pre-term infants and a major risk factor for preterm babies mortality and morbidity in neonatal intensive care unit(NICU). the majority of pre-term babies will require one or more blood transfusions during in NICU. Blood transfusion is a safe procedure but like all therapeutic interventions has risks associated with it and effort is made to reduce the number of transfusions that infants require during their stay on the neonatal unit.
Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy because of increased iron stores at birth. However there are controversies in incorporating delayed cord clamping practice in the management of third stage of labour globally. Concerning about the need for urgent resuscitation and temperature management, attendants encouraged to clamp the umbilical cord immediately so that post-natal resuscitation and care can start as soon as possible.However,umbilical cord milking allows for swift intervention and resuscitation and attention to thermal care and should take less than 10 seconds to complete.
The specific aim of this study is to investigate the effects of umbilical cord milking on preventing and decreasing anemia in very pre-term infants.
Primary Outcomes:
Hemoglobin (Hb), Hematocrit (Hct) and serum iron levels at birth, at 1 week,at 2 weeks of age.
Secondary Outcomes:
- Hemoglobin,hematocrit levels at 6 months of age.
- Anemia at 1 week of life and 6 months follow-up, defined as hemoglobin levels below the respective cutoffs.
- number of blood transfusions until 3 months corrected gestational age (CGA).
- short term clinical profile of neonates like jaundice, polycythemia etc.
- preterm infant complications such as lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), and cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected patent ductus arteriosus(PDA )requiring intervention prior to discharge home,incidence of intraventricular hemorrhage and late-onset sepsis,etc.
- Conditions
- Anemia
- Being tested
- umbilical cord milking, umbilical cord clamping immediately
- Keywords
- umbilical cord milking;anemia;placental transfusion
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord milkingProcedure or surgery
Infants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
umbilical cord clamping immediatelyProcedure or surgery
umbilical cord was cut immediately after birth
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord clamping immediately | Active comparator | Umbilical cord was clamped immediately, or as close as possible, after delivery of the infant's shoulders. (This was standard practice in the study hospital, thus it served as the "control" group). Receives: Procedure: umbilical cord clamping immediately |
| umbilical cord milking | Experimental | preterm baby were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds Receives: Procedure: umbilical cord milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentrations of Hemoglobin (Hb)
Measured: 48 hours after birth
concentrations of Hematocrit(Hct)
Measured: 48 hours after birth
serum ferritin level
Measured: 48 hours after birth
Secondary outcomes (4)
Hyperbilirubinemia requiring phototherapy
Hyperbilirubinemia requiring phototherapy (as per routine unit practice)
Measured: during first 2 weeks of age
incidence and numbers of blood transfusions
Measured: until 3 months corrected gestational age
Length of admission
Measured: Birth to discharge, expected average of 30 days
complication
composite of bronchopulmonary dysplasia , Necrotizing Enterocolitis , grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia , or death prior to discharge home
Measured: Birth to discharge, expected average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start30 Jun 2017
- Primary completion31 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai First Maternity and Infant Hospital, Yangpu District Central Hospital Affiliated to Tongji University
- Responsible party
- Principal investigator, Lijuan Xie, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- guangyu chen, Study chair, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023917
- Sponsor's protocol ID
- XH-16-050
- Status last verified
- Oct 2020
- First submitted
- 3 Jan 2017
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03023917
- Acronym / sponsor ID
- XH-16-050
- Conditions
- Anemia
- Keywords
- umbilical cord milking;anemia;placental transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai First Maternity and Infant Hospital, Yangpu District Central Hospital Affiliated to Tongji University
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Jan 2017 (estimated)
- 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 overall objective of the present study is to examine the effects of umbilical cord milking at birth in preterm infants to prevent and decrease anemia using a multi-center prospective randomized controlled trial comparing immediate cord clamping (standard at present) with umbilical cord milking.
Detailed description
Anemia is a significant problem for pre-term infants and a major risk factor for preterm babies mortality and morbidity in neonatal intensive care unit(NICU). the majority of pre-term babies will require one or more blood transfusions during in NICU. Blood transfusion is a safe procedure but like all therapeutic interventions has risks associated with it and effort is made to reduce the number of transfusions that infants require during their stay on the neonatal unit.
Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy because of increased iron stores at birth. However there are controversies in incorporating delayed cord clamping practice in the management of third stage of labour globally. Concerning about the need for urgent resuscitation and temperature management, attendants encouraged to clamp the umbilical cord immediately so that post-natal resuscitation and care can start as soon as possible.However,umbilical cord milking allows for swift intervention and resuscitation and attention to thermal care and should take less than 10 seconds to complete.
The specific aim of this study is to investigate the effects of umbilical cord milking on preventing and decreasing anemia in very pre-term infants.
Primary Outcomes:
Hemoglobin (Hb), Hematocrit (Hct) and serum iron levels at birth, at 1 week,at 2 weeks of age.
Secondary Outcomes:
- Hemoglobin,hematocrit levels at 6 months of age.
- Anemia at 1 week of life and 6 months follow-up, defined as hemoglobin levels below the respective cutoffs.
- number of blood transfusions until 3 months corrected gestational age (CGA).
- short term clinical profile of neonates like jaundice, polycythemia etc.
- preterm infant complications such as lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), and cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected patent ductus arteriosus(PDA )requiring intervention prior to discharge home,incidence of intraventricular hemorrhage and late-onset sepsis,etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| umbilical cord clamping immediately | Active comparator | Procedure: umbilical cord clamping immediatelyUmbilical cord was clamped immediately, or as close as possible, after delivery of the infant's shoulders. (This was standard practice in the study hospital, thus it served as the "control" group). |
| umbilical cord milking | Experimental | Procedure: umbilical cord milkingpreterm baby were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women in labour or with a plan for delivery at a gestational age less than 34 weeks gestation.
- Singleton pregnancy
- informed consent was obtained from the parent
Key exclusion criteria (7 listed)
- Multiple gestation
- Diagnosis of any of the following in the current pregnancy: hemorrhage requiring clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome of the fetus,anemia
- Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies
- Diagnosis at any time for the mother of any of the following: serious Diabetes, serious hypertension, chronic renal disease
- Infant with major congenital malformation
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 |
|---|---|---|
| umbilical cord milkingInfants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds | Procedure or surgery | umbilical cord milking |
| umbilical cord clamping immediatelyumbilical cord was cut immediately after birth | Procedure or surgery | umbilical cord clamping immediately |
Primary outcome
concentrations of Hemoglobin (Hb)
Time frame: 48 hours after birth
concentrations of Hematocrit(Hct)
Time frame: 48 hours after birth
serum ferritin level
Time frame: 48 hours after birth
4 secondary outcomes
Hyperbilirubinemia requiring phototherapy
Time frame: during first 2 weeks of age
incidence and numbers of blood transfusions
Time frame: until 3 months corrected gestational age
Length of admission
Time frame: Birth to discharge, expected average of 30 days
complication
Time frame: Birth to discharge, expected average of 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No
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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.
guangyu chen study chair
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing umbilical cord milking and umbilical cord clamping immediately in people with Anemia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 27 Oct 2020. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
concentrations of Hemoglobin (Hb) (time frame: 48 hours after birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2020.