Phase
Condition
N/ATreatment
HMO supplement
Clinical Study ID
Ages < 14 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent has been obtained from at least one parent (or otherlegally acceptable representative [LAR], if applicable)
Infant's parent(s)/LAR is of legal age of majority, has parental authority, mustunderstand the consent form and other relevant study documents, and is willing andable to fulfil the requirements of the study protocol
Infant gestational age is ≤ 34 weeks as determined by the first day of the mother'slast menstrual period or by fetal ultrasound
Infant birth weight ≤ 2500g
Infant postnatal age ≤ 14 days
Infant has tolerated trophic feeds (e.g., 10-15 mL/kg/day) for at least 24 hours buthas not yet reached full enteral feeding
Exclusion
Exclusion Criteria:
Infant is clinically unstable, for example:
Infant has hemodynamic instability as evidenced by clinical signs of sepsis,hypotension (MAP < 5th percentile for age for at least three hours), or isreceiving vasopressor drugs
Infant has received an exchange transfusion within the past 48 hours
Infant has had an episode of severe asphyxia at birth (PH less than 7.0)
Infant has signs of necrotizing enterocolitis according to modified Bellstaging criteria (stage IIA or higher)
Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy,gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)
Infant has other medical condition that, in the judgement of the investigator, wouldmake the child inappropriate for entry into the study
Participation in another interventional clinical study that may interfere with theresults of this study
Study Design
Connect with a study center
Kepler Universitätsklinikum Linz
Linz, 4020
AustriaActive - Recruiting
Evangelisches Waldkrankenhaus Spandau
Berlin-Spandau,
GermanyActive - Recruiting
Kinderklinik Darmstadt
Darmstadt,
GermanyActive - Recruiting
Wilhelmstift Hamburg
Hamburg,
GermanySite Not Available
Uniklinik Heidelberg
Heidelberg,
GermanyActive - Recruiting
Klinikum Nürnberg
Nürnberg, 90419
GermanyActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.