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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01121328
Other study ID # IRB#1
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date July 2011
Est. completion date September 2014

Study information

Verified date February 2019
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born premature <35 weeks of gestation.


Description:

In Egypt, 12-15.8% of live neonates are low birth weight and it is estimated that about one third of such infants are preterm [1] (UNICEF, 2001). In a study that Campbell et al. (2004) conducted in Egypt, the neonatal mortality rate was estimated to be 25 per 1000 live births. prematurity was considered the main cause of neonatal deaths (39%), followed by asphyxia (18%), infection (7%), especially in the late neonatal period, and congenital malformations (6%). A substantial proportion (29%) could not be classified [2]. In developing countries, prematurity was the main cause of early neonatal deaths (62%)[3] Autologous cord blood transfusion will be safe, and cheap. The preterm neonates need transfusion of whole blood or any of its components at a time during NICU admission.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group N/A to 30 Days
Eligibility Inclusion Criteria:

- Preterm neonates less than 34 weeks of gestation.

- Low birth weight less than 1500 grams

Exclusion Criteria:

- Congenital malformations.

- Suspected inborn error of metabolism.

- Suspected inherited neurologic disease.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Autologous cord blood transfusion for preterm neonates
Cord blood collection after delivery of the baby. Preservation of blood in blood bank. Transfusion of blood within the first 14 postnatal days to maintain Hb level above 10gm%.
Autologous cord blood transfusion
After delivery of the baby and before placental delivery in vaginal delivery. After delivery of the baby the placental will be taken out in cesarean section. sterilization of the umbilical cord will be done. Puncture of the umbilical cord vein with the needle of blood transfusion bag will be done. Blood will be kept in the blood bank. Blood grouping, haematocrit and CBC will be done for the cord blood.Maternal sample will be analysed simultaneously. Mononuclear layer will be separated within 6 hours and transfused to the preterm neonate immediately. RBCs will be separated and kept till need (Hb less than 10 gm%).

Locations

Country Name City State
Egypt Children's Hospital, Faculty of Medicine, Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Sahar M.A. Hassanein, MD

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of mechanical ventilation -No need for mechanical ventilation. 30 days
Secondary Survival Survival until 12 months of age.
Improved physical growth and weight gain.
Neurodevelopmental outcome at 6, 12 and 18 months of age.
18 months
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