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UMIN ID: UMIN000000990

Registered date:23/01/2008

A multicenter randomized control study of the effect of umbilical cord milking in avoiding red cell transfusions in extremely immature infants

Basic Information

Recruitment status	Complete: follow-up continuing
Health condition(s) or Problem(s) studied	extremely immature infants
Date of first enrollment	2008/01/01
Target sample size	566
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	First, umbilical cord is cut and clamped at 30cm from infants. Next the baby is placed on a radiant wormer. Finally, a Pediatrician straightens a kink of the umbilical cord and then milks the umbilical cord steadily once. early cord clamping (less than 30 seconds)

TO Original Data: UMIN

Outcome(s)

Primary Outcome	1) the probability of not needing transfusion and death 2) amount of blood transfusion within the first 4 weeks
Secondary Outcome	1) Mortality 2) Major complications (intraventricular hemorrage, chronic lung disease, periventricular leukomalasia, retionopath of prematurity, ontestinal perfolation) 3) serious adverse event 4) hemoglobin values within the first 24 hours 5) stabilization of blood pressure and use of volume expander and/or inotoropes 6) incidence of polycythemia and hyperbilirubinemia 7) developmental disorder at 18 months and 3 years of age (neurodevelopmental delay, cerebral palsy, epilepsy, visual impairment, hearing loss)

Primary Outcome

1) the probability of not needing transfusion and death 2) amount of blood transfusion within the first 4 weeks

Secondary Outcome

1) Mortality 2) Major complications (intraventricular hemorrage, chronic lung disease, periventricular leukomalasia, retionopath of prematurity, ontestinal perfolation) 3) serious adverse event 4) hemoglobin values within the first 24 hours 5) stabilization of blood pressure and use of volume expander and/or inotoropes 6) incidence of polycythemia and hyperbilirubinemia 7) developmental disorder at 18 months and 3 years of age (neurodevelopmental delay, cerebral palsy, epilepsy, visual impairment, hearing loss)

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	1) Major anomalies diagnosed in utero 2) intrauterin growth retardation ( less than 3SD) 3) monochorionic twins 4) super twin

Related Information

Primary Sponsor	Neonatal Resarch Network
Secondary Sponsor
Source(s) of Monetary Support	The Ministry of Health, Labor and Welfare
Secondary ID(s)

Contact

public contact
Name	Shigeharu Hosono
Address	30-1 Oyaguchi Itabashi Tokyo Japan Japan
Telephone	03-3972-8111(2442)
E-mail	hosonos@med.nihon-u.ac.jp
Affiliation	Nihon University School of Medicine Department of Pediatrics and Child Health
scientific contact
Name	Shigeharu Hosono
Address	30-1 Oyaguchi Itabashi Tokyo Japan Japan
Telephone	03-3972-8111(2442)
E-mail	hosono.shigeharu@nihon-u.ac.jp
Affiliation	Nihon University School of Medicine Department of Pediatrics and Child Health

TO Original Data: UMIN