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Cord Milking and Activity Of The Immune System In Preterm Infants

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ClinicalTrials.gov Identifier: NCT02043249
Recruitment Status : Unknown
Verified November 2013 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 23, 2014
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Preterm Delivery Other: CORD MILKING Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Cord Milking and Activity Of The Immune System In Preterm Infants
Study Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: CORD MILKING
WITHOUT MILKING
 Other: CORD MILKING
MILKING OF UMBILICAL CORD OF THE BABY
Other Name: UMBLICAL MILKING


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Mother's telephone questioning about the infant disease: fiver / hospitalization/tretment wit antibiotic. [ Time Frame: 3 and 6 month after delivery ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   24 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043249


Contacts
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Contact: RIVKA FRANKEL, M.D 972-528721581 RIVKA.LUTVACK@GMAIL.COM
Contact: ESTER PRI-OR 972-506629699 ESTERP@HY.HEALTH.CO.IL

Locations
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Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Contact: RIVKA FRANKEL, M.D    972-528721581    RIVKA.LUTVACK@GMAIL.COM   
Principal Investigator: RIVKA FRANKEL, M.D         
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Rivka Frenkel, MD Hellel Yaffe Medical Center
More Information
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT02043249    
Other Study ID Numbers: HYMC 0042-13
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: November 2013
Keywords provided by Hillel Yaffe Medical Center:
DELAYED CORD CLAMPING
MILKING OF CORD
PREMATURE INFANTS
LEVEL OF IgG IN NEONATES
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications