Preterm DeliveryNCT02043249
Cord Milking and Activity Of The Immune System In Preterm Infants
A study testing CORD MILKING in people with Preterm Delivery, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
In the embry life there is a passage of IgG type, from the mother to tha embryoyo and only in the age of 3-5 month after birth the infant start to develop them by himself. In preterm infants the starting point of the level of the IgG's is lower from the level of term infants. Read more about this study
- Who is it for?
- Ages 24 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery
- What is being tested?
- CORD MILKING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jan 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 24 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- PRETERM INFANS BETWEEN 24+0/7 TO 36
- 6/7 WEEKS.
- NEWBORN FOR MOTHER WHO AGREE TO PARTICIPATE IN THE RESEARCH WHO DELIVER IN NORMAL DELIVERY / PLANED OR URGENT CESARIAN DELIVERY
Who cannot join
- INTRA UTERINE GROWTH RESTRICTION, INFANT UNDER 10% TO AGE OF PREGNANCY.
- MOTHER WHO IS NOT WILLING TO PARTICIPATE IN RESEARCH.
- NEONATES TO MOTHER WHOM SUSPECTED TO BE IMMUNO- COMPROMISED OR HAVING INFECTION AROUND DELIVERY.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
RIVKA FRANKEL, M.D, 972-528721581, RIVKA.LUTVACK@GMAIL.COM
RIVKA FRANKEL, M.D
About this study
In the embry life there is a passage of IgG type, from the mother to tha embryoyo and only in the age of 3-5 month after birth the infant start to develop them by himself.
In preterm infants the starting point of the level of the IgG's is lower from the level of term infants.
Delayed cord clamping /milking it was prooved in many researches as benificial in terms of : levels of hemoglobin; hematocrit and feritin in the neonats. Also benefits were proved by means of less need for blood tranfusion, less intra ventricular hemorrhage; necrotzing entero colitis and iron deficiency anemia. The hypothesis is that delayed clamping /milking it will increse the level of IgG's in preterm infants. The end point hypothesis is that delayed cord clamping /milking cause to less fever disease or hospitalization it the neonats.
Read the detailed description
In this study we come to a prove that if we miking the cord in preterm infats we will increse the level of IgG .
- Conditions
- Preterm Delivery
- Being tested
- CORD MILKING
- Keywords
- DELAYED CORD CLAMPING, MILKING OF CORD, PREMATURE INFANTS, LEVEL OF IgG IN NEONATES
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORD MILKINGOther
Also called UMBLICAL MILKING
MILKING OF UMBILICAL CORD OF THE BABY
| Study group | Role | What they receive |
|---|---|---|
| CORD MILKING | No intervention | WITHOUT MILKING Receives: Other: CORD MILKING |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of IgG in preterm infats
Blood test for IgG's level from the baby in :
at delivery . 24 hours after delivery. before discharg from hospital
Measured: 24 hours after delivery and after 24 hours..
Secondary outcomes (1)
Mother's telephone questioning about the infant disease: fiver / hospitalization/tretment wit antibiotic.
Phone call interview of the mother in 3 and 6 month from delivery about : emergengy room admission; hospitalization, fever disease and antibiotic treatment in this time period.
Measured: 3 and 6 month after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm DeliveryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rivka Frenkel, MD, Principal investigator, Hellel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043249
- Sponsor's protocol ID
- HYMC 0042-13
- Status last verified
- Nov 2013
- First submitted
- 13 Nov 2013
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cord Milking and Activity Of The Immune System In Preterm Infants
- ClinicalTrials.gov ID
- NCT02043249
- Acronym / sponsor ID
- HYMC 0042-13
- Conditions
- Preterm Delivery
- Keywords
- DELAYED CORD CLAMPING, MILKING OF CORD, PREMATURE INFANTS, LEVEL OF IgG IN NEONATES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 23 Jan 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.
In the embry life there is a passage of IgG type, from the mother to tha embryoyo and only in the age of 3-5 month after birth the infant start to develop them by himself.
In preterm infants the starting point of the level of the IgG's is lower from the level of term infants.
Delayed cord clamping /milking it was prooved in many researches as benificial in terms of : levels of hemoglobin; hematocrit and feritin in the neonats. Also benefits were proved by means of less need for blood tranfusion, less intra ventricular hemorrhage; necrotzing entero colitis and iron deficiency anemia. The hypothesis is that delayed clamping /milking it will increse the level of IgG's in preterm infants. The end point hypothesis is that delayed cord clamping /milking cause to less fever disease or hospitalization it the neonats.
Detailed description
In this study we come to a prove that if we miking the cord in preterm infats we will increse the level of IgG .
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CORD MILKING | No intervention | Other: CORD MILKINGWITHOUT MILKING |
Who may qualify
- Ages
- 24 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- PRETERM INFANS BETWEEN 24+0/7 TO 36
Key exclusion criteria (3 listed)
- INTRA UTERINE GROWTH RESTRICTION, INFANT UNDER 10% TO AGE OF PREGNANCY.
- MOTHER WHO IS NOT WILLING TO PARTICIPATE IN RESEARCH.
- NEONATES TO MOTHER WHOM SUSPECTED TO BE IMMUNO- COMPROMISED OR HAVING INFECTION AROUND DELIVERY.
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 |
|---|---|---|
| CORD MILKINGAlso: UMBLICAL MILKINGMILKING OF UMBILICAL CORD OF THE BABY | Other | CORD MILKING |
Primary outcome
levels of IgG in preterm infats
Time frame: 24 hours after delivery and after 24 hours..
Blood test for IgG's level from the baby in : at delivery . 24 hours after delivery. before discharg from hospital
1 secondary outcome
Mother's telephone questioning about the infant disease: fiver / hospitalization/tretment wit antibiotic.
Time frame: 3 and 6 month after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
Related trials for Preterm Delivery
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)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Rivka Frenkel, MD principal investigator
Hellel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CORD MILKING in people with Preterm Delivery, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 3 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 23 Jan 2014. 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 Israel. 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?
Contact RIVKA FRANKEL, M.D (972-528721581, RIVKA.LUTVACK@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of IgG in preterm infats (time frame: 24 hours after delivery and after 24 hours..). 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 23 Jan 2014.