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Cord Milking and Activity Of The Immune System In Preterm Infants

Primary Purpose

Preterm Delivery

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CORD MILKING
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Delivery focused on measuring DELAYED CORD CLAMPING, MILKING OF CORD, PREMATURE INFANTS, LEVEL OF IgG IN NEONATES

Eligibility Criteria

24 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

CORD MILKING

Arm Description

WITHOUT MILKING

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 13, 2013
Last Updated
January 19, 2014
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02043249
Brief Title
Cord Milking and Activity Of The Immune System In Preterm Infants
Official Title
Cord Milking and Activity Of The Immune System In Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery
Keywords
DELAYED CORD CLAMPING, MILKING OF CORD, PREMATURE INFANTS, LEVEL OF IgG IN NEONATES

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CORD MILKING
Arm Type
No Intervention
Arm Description
WITHOUT MILKING
Intervention Type
Other
Intervention Name(s)
CORD MILKING
Other Intervention Name(s)
UMBLICAL MILKING
Intervention Description
MILKING OF UMBILICAL CORD OF THE BABY
Primary Outcome Measure Information:
Title
levels of IgG in preterm infats
Description
Blood test for IgG's level from the baby in : at delivery . 24 hours after delivery. before discharg from hospital
Time Frame
24 hours after delivery and after 24 hours..
Secondary Outcome Measure Information:
Title
Mother's telephone questioning about the infant disease: fiver / hospitalization/tretment wit antibiotic.
Description
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.
Time Frame
3 and 6 month after delivery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RIVKA FRANKEL, M.D
Phone
972-528721581
Email
RIVKA.LUTVACK@GMAIL.COM
First Name & Middle Initial & Last Name or Official Title & Degree
ESTER PRI-OR
Phone
972-506629699
Email
ESTERP@HY.HEALTH.CO.IL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rivka Frenkel, MD
Organizational Affiliation
Hellel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RIVKA FRANKEL, M.D
Phone
972-528721581
Email
RIVKA.LUTVACK@GMAIL.COM
First Name & Middle Initial & Last Name & Degree
RIVKA FRANKEL, M.D

12. IPD Sharing Statement

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Cord Milking and Activity Of The Immune System In Preterm Infants

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