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| Name | Class |
|---|---|
| Shanghai First Maternity and Infant Hospital | OTHER |
| Yangpu District Central Hospital Affiliated to Tongji University | OTHER |
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The overall objective of the present study is to examine the effects of umbilical cord milking at birth in preterm infants to prevent and decrease anemia using a multi-center prospective randomized controlled trial comparing immediate cord clamping (standard at present) with umbilical cord milking.
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.
Primary Outcomes:
Hemoglobin (Hb), Hematocrit (Hct) and serum iron levels at birth, at 1 week,at 2 weeks of age.
Secondary Outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| umbilical cord clamping immediately | Active Comparator | 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). |
|
| umbilical cord milking | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord milking | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| concentrations of Hemoglobin (Hb) | 48 hours after birth | |
| concentrations of Hematocrit(Hct) | 48 hours after birth | |
| serum ferritin level | 48 hours after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperbilirubinemia requiring phototherapy | Hyperbilirubinemia requiring phototherapy (as per routine unit practice) | during first 2 weeks of age |
| incidence and numbers of blood transfusions | until 3 months corrected gestational age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| guangyu chen | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital | Shanghai | Shanghai Municipality | 200092 | China |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| umbilical cord clamping immediately | Procedure | umbilical cord was cut immediately after birth |
|
| Length of admission | Birth to discharge, expected average of 30 days |
| complication | composite of bronchopulmonary dysplasia , Necrotizing Enterocolitis , grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia , or death prior to discharge home | Birth to discharge, expected average of 30 days |