The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in Preterms
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03023917|
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Procedure: umbilical cord milking Procedure: umbilical cord clamping immediately||Not Applicable|
Anemia is a significant problem for pre-term infants and a major risk factor for preterm babies mortality and morbidity in neonatal intensive care unit(NICU). the majority of pre-term babies will require one or more blood transfusions during in NICU. Blood transfusion is a safe procedure but like all therapeutic interventions has risks associated with it and effort is made to reduce the number of transfusions that infants require during their stay on the neonatal unit.
Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy because of increased iron stores at birth. However there are controversies in incorporating delayed cord clamping practice in the management of third stage of labour globally. Concerning about the need for urgent resuscitation and temperature management, attendants encouraged to clamp the umbilical cord immediately so that post-natal resuscitation and care can start as soon as possible.However,umbilical cord milking allows for swift intervention and resuscitation and attention to thermal care and should take less than 10 seconds to complete.
The specific aim of this study is to investigate the effects of umbilical cord milking on preventing and decreasing anemia in very pre-term infants.
To study the effect of umbilical cord milking on hemoglobin (Hb), Hematocrit (Hct)and ferritin at birth, at seventh day and three months of age.
To study the effect of umbilical cord milking on short term clinical profile of neonates like jaundice, polycythemia etc.
To evaluate the number of blood transfusions until 3 months corrected gestational age (CGA), To assess preterm infant complications such as lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), and cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected patent ductus arteriosus(PDA )requiring intervention prior to discharge home,incidence of intraventricular hemorrhage and late-onset sepsis,etc.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial|
|Actual Study Start Date :||June 30, 2017|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: umbilical cord clamping immediately
Umbilical cord was clamped immediately, or as close as possible, after delivery of the infant's shoulders. (This was standard practice in the study hospital, thus it served as the "control" group).
Procedure: umbilical cord clamping immediately
umbilical cord was cut immediately after birth
Experimental: umbilical cord milking
preterm baby were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
Procedure: umbilical cord milking
Infants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
- concentrations of Hemoglobin (Hb) [ Time Frame: 48 hours after birth ]
- concentrations of Hematocrit(Hct) [ Time Frame: 48 hours after birth ]
- serum ferritin level [ Time Frame: 48 hours after birth ]
- Hyperbilirubinemia requiring phototherapy [ Time Frame: during first 2 weeks of age ]Hyperbilirubinemia requiring phototherapy (as per routine unit practice)
- incidence and numbers of blood transfusions [ Time Frame: until 3 months corrected gestational age ]
- Length of admission [ Time Frame: Birth to discharge, expected average of 30 days ]
- complication [ Time Frame: Birth to discharge, expected average of 30 days ]composite of bronchopulmonary dysplasia , Necrotizing Enterocolitis , grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia , or death prior to discharge home
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023917
|Contact: Lijuan XIE, director||021-25078999 ext email@example.com|
|Contact: hongping xia||021-25078999 ext firstname.lastname@example.org|
|Shanghai, Shanghai, China, 200092|
|Contact: lijuan xie 021-25078999 ext 8395 email@example.com|
|Study Chair:||guangyu chen||Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|