TOLERANCE OF MILK FEEDS IN PRETERM, VERY LOW BIRTH WEIGHT BABIES: THE USE OF GLYCERINE SUPPOSITORIES
Phase 1
- Conditions
- The problem is inability to sustain enteral feeding in very low birth weight babies due to feed intolerance. The necessity for parenteral feeding creates risk of sepsis, cholestasis,increased oxygen requirement and abdominal distension
- Registration Number
- EUCTR2005-000302-31-GB
- Lead Sponsor
- HS Lanarkshire, Primary Care Operating Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
Inclusion and Exclusion Criteria
The study group will include all preterm babies born at Wishaw General Hospital at less than 32 weeks’ gestation.
Babies are stratified in two main groups based on their gestational age- a) < 28 weeks and b) 28-31 weeks.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Babies will be excluded from the study if they have major dysmorphic features, are found to have a structural gastrointestinal anomaly, develop Necrotising Enterocolitis or suffer perinatal hypoxic ischaemic encephalopathy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method