Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants

Background:

Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human milk and preterm formulas contain DHA and AA, but at lower concentrations than required to approximate utero accretion rate.

Objective:

To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age.

Design:

A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal centers.

Subjects and methods:

Infants with birth weight \< 1.5 kg are randomized to either an intervention or a control group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100 ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek, USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for fatty acid pattern using high performance liquid chromatography.


Options:
A: Inclusion Criteria:

* Birth weight \< 1500 g
* Born at one of 4 participating neonatal centers in Norway

Exclusion Criteria:

* Cerebral haemorrhage (stage 3 or 4)
* Major congenital malformations that are supposed to affect growth and development
* Illness that require prolonged parenteral nutrition (\>4 weeks)
B: Inclusion Criteria:

* Infant in good health, full term, singleton birth and 84-156 days of age at enrollment. Male infants only to be enrolled for primary variable measures.
* Restrict use of certain medications or home remedies, herbal preparations, probiotics or rehydration/intravenous (IV) fluids.

Exclusion Criteria:

* Adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Infant has been treated with antibiotics 3 days prior to enrollment.
* Infant has received probiotics-containing products 3 days prior to enrollment.
C: Inclusion Criteria:

* preterm birth
* birth weight between 1000 and 2200 g
* more than 80 % of energy intake from infant formula or human milk at enrollment

Exclusion Criteria:

* apparent genetic, gastrointestinal or metabolic disorders
* artificial ventilation or oxygen supply \> 30% at the time of enrollment
* administration of parenteral fat emulsion (\> 1 g/kg/day for more than seven days) before or after study entry
D: Inclusion Criteria:

* weight at birth equal or above 2500 g;
* gestational age between 37 and 42 completed weeks;
* single birth;
* absence of neonatal or birth abnormalities;
* Apgar score greater than or equal to 7 at 5 m;
* white parents.

Exclusion Criteria:

* presence of neonatal diseases requiring hospitalisation for longer than 7 days;
* unknown father;
* parents unable to understand the protocol requirements and to fill out the infants diary;
* infant already enrolled or selected for another clinical study.

Answer: A