Cord Milking and Activity Of The Immune System In Preterm Infants

Preterm Delivery Clinical Trial

Official title:

Cord Milking and Activity Of The Immune System In Preterm Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02043249
• Other study ID #: HYMC 0042-13
• Status: Not yet recruiting
• Phase: N/A
• First received: November 13, 2013
• Last updated: January 19, 2014
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2013
• Source: Hillel Yaffe Medical Center
• Contact: RIVKA FRANKEL, M.D
• Phone: 972-528721581
• Email: RIVKA.LUTVACK[@]GMAIL.COM
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 24 Weeks to 37 Weeks

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth
• Preterm Delivery

Intervention

Other:
• CORD MILKING
MILKING OF UMBILICAL CORD OF THE BABY

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..	No
Secondary	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.	3 and 6 month after delivery	No