Cord Milking and Activity Of The Immune System In Preterm Infants

NCT ID: NCT02043249

Last Updated: 2014-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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

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Preterm Delivery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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CORD MILKING

WITHOUT MILKING

Group Type NO_INTERVENTION

CORD MILKING

Intervention Type OTHER

MILKING OF UMBILICAL CORD OF THE BABY

Interventions

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CORD MILKING

MILKING OF UMBILICAL CORD OF THE BABY

Intervention Type OTHER

Other Intervention Names

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UMBLICAL MILKING

Eligibility Criteria

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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.
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rivka Frenkel, MD

Role: PRINCIPAL_INVESTIGATOR

Hellel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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RIVKA FRANKEL, M.D

Role: CONTACT

972-528721581

ESTER PRI-OR

Role: CONTACT

972-506629699

Facility Contacts

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RIVKA FRANKEL, M.D

Role: primary

972-528721581

Other Identifiers

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HYMC 0042-13

Identifier Type: -

Identifier Source: org_study_id

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