Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
Brief Summary: This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.

The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.


Options:
A: Inclusion Criteria:

* Preterm infants ≦ 34 weeks gestational age and birth weight below 1500 gm and who survive to NICU are eligible for the trial.

Exclusion Criteria:

* severe asphyxia (stage III),
* fetal chromosomal anomalies,
* cyanotic congenital heart disease,
* congenital intestinal atresia, gastroschisis, omphalocele, active upper gastric intestinal bleeding,
* lacking/refused of parental consent,
* those who are fasted for \>3 weeks during the study period.
B: Inclusion Criteria:

* Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days

Exclusion Criteria:

* Chromosomal anomalies.
* Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
* Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
* Parental refusal
* Prior enrollment into a conflicting clinical trial
C: Inclusion Criteria:

* Infant's birth weight ≤1700 g.
* Infant's gestational age ≥ 27 weeks + 0 days and ≤ 32 weeks + 6 days.
* Infant is clinically stable
* Infants are eligible to start HMOs / placebo as soon as possible after birth, but still within the first 7 days of life.
* Written informed consent has been obtained from the parents/legally acceptable representative (LAR).

Exclusion Criteria:

* Parents not willing / not able to comply with the requirements of study protocol.
* Infants receiving ongoing prophylactic antifungal therapies.
* Infants experiencing early onset sepsis.
* Major congenital or chromosomal abnormality known to affect growth.
* Liver failure.
* Severe intrauterine growth restriction (IUGR) as defined by having birth weight less than 2nd percentile on the Fenton growth chart.
* Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification) .
* Infant in critical condition needing intubation or inotropic agents for treatment.
* Infant requiring prolonged (more than 3 doses) of steroid treatment.
* Infants' participation in another interventional clinical trial that would have significant impact on current study's results.
* Infants who have already achieved Full Enteral Feeding (FEF) prior to enrolment, using the definition accepted by neonatal unit as per standard practice (150 mL/kg/day).
D: Inclusion Criteria:

* Weight between 800 - 1500g
* Tolerating enteral feeding within 48 hours
* Having obtained his/her parents or legal representative informed consent

Exclusion Criteria:

* Chromosomal abnormality
* Hydrops featalis
* Congenital malformation of the gastrointestinal tract
* Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance
* Currently participating in another clinical trial

Answer: B