Status:
COMPLETED
Probiotics in the Management of Necrotizing Enterocolitis in HIV-exposed Premature Infants
Lead Sponsor:
University of Stellenbosch
Conditions:
Necrotizing Enterocolitis
Eligibility:
All Genders
25-34 years
Phase:
PHASE3
Brief Summary
A randomized, double blind, placebo controlled clinical trial was conducted in the neonatal high care unit of Tygerberg Children's Hospital (TBCH) Cape Town, South Africa for the period July 2011 to A...
Detailed Description
A randomized, double blind, placebo controlled clinical trial was conducted in the neonatal high care unit of Tygerberg Children's Hospital (TBCH) Cape Town, South Africa for the period July 2011 to A...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Consecutive HIV positive or negative mothers, who gave birth to a premature, very-low birth weight infant at Tygerberg Childrens Hospital (TBCH) and consented to participate in the study.
- Only mothers who decided to breastfeed after counseling, regardless of their HIV status were included
- All HIV positive mothers are counseled routinely at TBCH about the risks and benefits of breastfeeding and bottle-feeding relating to the prevention of mother to child transmission scheme.
- HIV positive mothers that were on the PMTCT treatment regiment and if antiretroviral medication was prescribed. Mothers receiving Nevirapine and Zidovudine as well as those receiving highly active antiretroviral medication were included in the study.
- Premature/ low birth weight infants
- Admission or transfer's to wards G1, G2, J3 and G8 at TBCH
- Patients who were transferred to the kangaroo mother care unit in TBCH
- Birth weight \<1 250g
- Premature infant with a birth age of \<34 weeks gestation
- Male and female subjects
- Patients that received own mother's breast milk
- Patients that received donor breast milk due to the following circumstances:
- If donor breast milk was given as a supplemental feed due to insufficient breast milk supply from the mother
- When the mother was unavailable e.g. home visits over weekends, continuation of work
- If the mother was ill and unable to breastfeed the infant e.g. ICU admission
- Premature very-low birth weight infants that were HIV exposed or HIV unexposed
- HIV exposed premature very-low birth weight infants that received ARV medication
- Exclusion Criteria:
- Mothers that received medications that is contra-indicated for breastfeeding
- These medications include the following drug classes: anticoagulants, cytotoxics and psychoactive drugs e.g. antidepressants , antipsychotics chlorpromazine and individual drugs detectable in breast milk that pose theoretical risk.
- Mothers with active Mycobacterium tuberculosis who were still potentially infectious and who should not have been in direct contact with the infant were be excluded from this study
- HIV positive mothers that presented clinically sick with a CD4 cell count \<200cells/µl
- Premature/ low birth weight infants
- Birth weight \< 500g
- Premature infant with a birth age of \<25 weeks gestation
- Prenatal/ postnatal diagnosis of gastroschisis, large omphalocele or congenital diaphragmatic hernia
- Infants with congenital intestinal obstruction or perforation
- Infants with major congenital malformations and/or developmental disabilities pertaining to the gastrointestinal tract
- Infants with perinatal asphyxia
- Infants with a positive diagnosis of a complex heart disease
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT01868737
Start Date
July 1 2011
End Date
August 1 2012
Last Update
July 22 2013
Active Locations (1)
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1
Tygerberg Hospital
Tygerberg, Cape Town, Western Cape, South Africa, 7500