Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso
Brief Summary: Intrauterine Growth Retardation is the most important determinant of mortality and morbidity in the neonatal period. It is also a very important factor in predicting nutritional status, health and development in childhood. It even influences health in adult life, contributing to the vicious cycle of disease and poverty. The high rate IUGR in DCs represents therefore a major public health problem. Maternal malnutrition is usually assumed to be a major determinant of the problem in these countries. An increasing amount of evidence points to the potential role played by micronutrient deficiencies during pregnancy. The adverse effect on birthweight of maternal iron deficiency anaemia, lack of zinc and lack of iodine have been documented. A similar effect is suspected for Vitamin A, Magnesium, Calcium, Copper,Thiamine, Pyridoxine and Folic acid. It seems that not one specific deficiency alone is responsible for this adverse effect, but rather a combination of them. Therefore, it is expected that covering needs of pregnant women by a multivitamin-mineral supplement will have an effect of public health importance on children's health.

This study has the objective of improving children's health by preventing intrauterine growth retardation through the provision of multivitamin-mineral supplements during pregnancy.

This research includes 2 constituents:

1. a pilot phase during which socio-anthropological, nutritional and epidemiological aspects of IUGR will be assessed through qualitative and epidemiological methods.
2. a double-blind, randomised, placebo-controlled trial, including 1215 pregnant women aimed at testing 3 hypotheses: supplementing pregnant women with a multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a positive effect on health and growth during infancy; covering nutritional needs of lactating women with a multivitamin-minerals mix during 3 months after delivery will improve health and growth of infants.

The trial is planned in Hounde District, Burkina Faso, in collaboration with Centre Muraz, which plays a leader role in research and services providing at the district level and in policy recommendations at the national level. This will ensure that the study findings are incorporated into on-going district programmes with possible replication at the national level. The research lasts from June 2003 to October 2006.


Options:
A: Inclusion Criteria:

All the women of child-bearing age (15-44 years) living in the study area (4 100) will be visited monthly to assess early pregnancy and will be invited to participate in the trial.

Exclusion Criteria:

Will be excluded from the study women :

* planning to move outside the district within the 2 years following the start of the trial.
* regularly using a contraceptive method.
* already pregnant at the start of the trial.
B: Inclusion Criteria:

* Personal history of asthma, eczema, allergic rhinitis or a history of asthma, eczema, allergic rhinitis in the biological father of the child
* Gestational age between 10 and 18 weeks at the time of randomization
* Maternal age between 18 and 39 years
* Not a current smoker
* English or Spanish speaking
* Intent to participate for the full 4 years (through Pregnancy and then until the 3rd birthday of the child)

Exclusion Criteria:

* Not meeting inclusion criteria
* Gestational age greater than 18 weeks
* Presence of chronic medical conditions
* Taking vitamin D supplements containing more than 2000 IU/day of vitamin D3
* Multiple gestation pregnancy (twins, triplets)
* Pregnancy achieved by assisted reproduction techniques (e.g., IUI, IVF)
C: Inclusion Criteria:

* Mother plans to breastfeed exclusively for at least six months
* Mother is in good health
* Infant is 35 weeks' gestation or greater
* Breastfeeding infant is in good health ( Level I nursery; or Level II nursery but not requiring oxygen therapy or parenteral nutrition beyond first 72 hours).

Exclusion Criteria:

* Mother does not plan to breastfeed exclusively for the first six months (plans to use formula for infant's feedings during the first six months
* Infant has been admitted to Neonatal Intensive Care unit requiring oxygen therapy or parental nutrition beyond the first 72 hours
* Infant is less than 35 weeks' gestation
* Infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern
* Mother has a history of endocrine dysfunction involving parathyroid gland, diabetes, or calcium abnormalities related to renal disease such that calcium parameters are abnormal
* Mother has history of hypercalciuria
D: Inclusion Criteria:

* Preterm Infants (28-37 wk gestational age)
* Late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. Clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs:

  1. Temperature instability (hypothermia, hyperthermia);
  2. Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);
  3. Neurologic (hypotonia, lethargy, seizures);
  4. Gastrointestinal (feeding intolerance, abdominal distension).

Exclusion Criteria:

* Major congenital anomalies.
* Chromosomal anomalies.
* Known inborn error(s) of metabolism

Answer: A