Cord Milking and Activity Of The Immune System In Preterm Infants
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 23, 2014
November 1, 2013
2 years
November 13, 2013
January 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
24 hours after delivery and after 24 hours..
Secondary Outcomes (1)
Mother's telephone questioning about the infant disease: fiver / hospitalization/tretment wit antibiotic.
3 and 6 month after delivery
Study Arms (1)
CORD MILKING
NO INTERVENTIONWITHOUT MILKING
Interventions
Eligibility Criteria
You may qualify if:
- PRETERM INFANS BETWEEN 24+0/7 TO 36
- /7 WEEKS.
- NEWBORN FOR MOTHER WHO AGREE TO PARTICIPATE IN THE RESEARCH WHO DELIVER IN NORMAL DELIVERY / PLANED OR URGENT CESARIAN DELIVERY
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, 38100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rivka Frenkel, MD
Hellel Yaffe Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2013
First Posted
January 23, 2014
Study Start
January 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 23, 2014
Record last verified: 2013-11