Cord Milking and Activity Of The Immune System In Preterm Infants

January 19, 2014 updated by: Hillel Yaffe Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CORD MILKING
WITHOUT MILKING
Other: CORD MILKING
MILKING OF UMBILICAL CORD OF THE BABY
Other Names:
  • UMBLICAL MILKING

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours after delivery and after 24 hours..

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 and 6 month after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Rivka Frenkel, MD, Hellel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

January 19, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

January 23, 2014

Last Update Submitted That Met QC Criteria

January 19, 2014

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC 0042-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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