Post LaUnch monitoring pretermS.
- Conditions
- Preterm infants with extremely low birth weight (< 1000 g).
- Registration Number
- NL-OMON24765
- Lead Sponsor
- Danone Research - Centre for Specialised Nutrition
- Brief Summary
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Birth weight of < 1000 g;
2. Gestational age s 36 weeks;
Exclusion Criteria
1. (Anticipated) transfer to another hospital within 2 weeks after start of full enteral feeding;
2. Major congenital disorders interfering with the protocol requirements as per investigator's clinical judgement;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Growth (gain in body weight, length and head circumference);<br /><br>2. Gastrointestinal symptoms;<br /><br>3. Serious Adverse Events (SAEs).
- Secondary Outcome Measures
Name Time Method 1. Parameters to assess digestive function in stool;<br /><br>2. Parameters to assess digestive function in gastric aspirate.