Premature InfantNCT02187510
Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section
A study testing Umbilical cord milking and Delayed cord clamping in people with Premature Infant and Umbilical Cord, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether the umbilical cord milking in preterm infants born by cesarian section less than 34 weeks is more effective than delayed cord clamping to obtain higher levels of hemoglobin. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Infant, Umbilical Cord, Milking
- What is being tested?
- Umbilical cord milking and Delayed cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Mar 2016
- 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
- Preterm infants less than 34 weeks' gestation born by cesarean section
Who cannot join
- Inability to obtain informed consent from the mother state
- Monochorionic-monoamniotic twin gestation
- Placenta abruption
- Uterine rupture
- Transplacental cesarean
- Hydrops fetalis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Umbilical Cord Milking Compared With Delayed Cord Clamping to Increase Plancental Transfusion in Preterm Infants Less Than 34 Weeks' Gestation Born by Cesarean Section. Randomised Clinical Trial
The purpose of this study is to determine whether the umbilical cord milking in preterm infants born by cesarian section less than 34 weeks is more effective than delayed cord clamping to obtain higher levels of hemoglobin.
- Conditions
- Premature Infant, Umbilical Cord, Milking, Delayed Clamping
- Being tested
- Umbilical cord milking, Delayed cord clamping
- Keywords
- Hemodynamics, Premature Infant, Umbilical cord, Milking, Delayed clamping
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord milkingProcedure or surgery
Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord.
Delayed cord clampingProcedure or surgery
Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord milking | Experimental | Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord. Receives: Procedure: Umbilical cord milking |
| Delayed cord clamping | Active comparator | Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord. Receives: Procedure: Delayed cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin
g/dl
Measured: 1 hour and 24 hours at born
Secondary outcomes (9)
Apgar Score
Basic score to mesure the newborn status. From 0 to 10.
Measured: 1 and 5 minutes
Arterial pressure
Mean of systolic and dyastolic arterial pressure in mm Hg
Measured: 2, 6, 12, 24, 36 and 48 hours of life
Orine volume
Total volume of orine at 24 and 48 hours of life. Total ml.
Measured: 24 and 48 hours of life
Use of vasopresors drugs
To use or not to use the vasopresors drugs during the first 24 hours of life
Measured: 24 hours of life
Number of concentrate hematies transfusion
Total number of concentrate hematies transfusions during the hospital stay. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.
Measured: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Intraventricular hemorrhage
Presence of intraventricular hemorrhage mesured by cerebral ultrasound Degree of the hemorrhage by Papile
Measured: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Bronchopulmonary dysplasia
Presence of Bronchopulmonary dysplasia and the degree, mesured by Spanish classification (M. Sanchez Luna)
Measured: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Total intensive care unit stay
Mesured in days. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.
Measured: Participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Hematocrit
In percentage
Measured: 1 hour and 24 hours at born
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mònica Domingo Puiggròs, Corporacion Parc Tauli
- Investigators
- Monica Domingo-Puiggros, MD, Study director, Corporacio Sanitaria Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187510
- Sponsor's protocol ID
- CSPTNeonat2014_01
- Status last verified
- Apr 2016
- First submitted
- 6 Jun 2014
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Milking Compared With Delayed Cord Clamping to Increase Plancental Transfusion in Preterm Infants Less Than 34 Weeks' Gestation Born by Cesarean Section. Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02187510
- Acronym / sponsor ID
- CSPTNeonat2014_01
- Conditions
- Premature Infant, Umbilical Cord, Milking, Delayed Clamping
- Keywords
- Hemodynamics, Premature Infant, Umbilical cord, Milking, Delayed clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Jul 2014 (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 purpose of this study is to determine whether the umbilical cord milking in preterm infants born by cesarian section less than 34 weeks is more effective than delayed cord clamping to obtain higher levels of hemoglobin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord milking | Experimental | Procedure: Umbilical cord milkingOnce the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord. |
| Delayed cord clamping | Active comparator | Procedure: Delayed cord clampingOnce the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Preterm infants less than 34 weeks' gestation born by cesarean section
Key exclusion criteria (6 listed)
- Inability to obtain informed consent from the mother state
- Monochorionic-monoamniotic twin gestation
- Placenta abruption
- Uterine rupture
- Transplacental cesarean
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 milkingOnce the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord. | Procedure or surgery | Umbilical cord milking |
| Delayed cord clampingOnce the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord. | Procedure or surgery | Delayed cord clamping |
Primary outcome
Haemoglobin
Time frame: 1 hour and 24 hours at born
g/dl
9 secondary outcomes
Apgar Score
Time frame: 1 and 5 minutes
Arterial pressure
Time frame: 2, 6, 12, 24, 36 and 48 hours of life
Orine volume
Time frame: 24 and 48 hours of life
Use of vasopresors drugs
Time frame: 24 hours of life
Number of concentrate hematies transfusion
Time frame: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Intraventricular hemorrhage
Time frame: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Bronchopulmonary dysplasia
Time frame: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Total intensive care unit stay
Time frame: Participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Hematocrit
Time frame: 1 hour and 24 hours at born
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 28 Apr 2016.
Related trials for Premature Infant
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Monica Domingo-Puiggros, MD study director
Corporacio Sanitaria Parc Tauli
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 Delayed cord clamping in people with Premature Infant and Umbilical Cord, run by Corporacion Parc Tauli at 1 site in Spain.
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 6 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 28 Apr 2016. 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 Spain. 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?
Haemoglobin (time frame: 1 hour and 24 hours at born). 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 28 Apr 2016.