Clinical Research Directory
Browse clinical research sites, groups, and studies.
Determination of Clinical Phenotypes of Intrauterine Growth Restriction in Term Infants Based on Body Composition
Sponsor: Centro Hospitalar de Lisboa Central
Summary
Intrauterine growth restriction (IUGR) is defined as the inability of the fetus to fulfill its genetic growth potential. "Small for gestational age" (SGA) is the most commonly used indicator for diagnosing IUGR. However, this definition does not consider intrauterine growth trajectory or physical characteristics at birth. SGA is based on the relationship between birth weight and gestational age, and does not address anthropometric measurements at birth or prenatal indicators, such as biometric, biophysical, and Doppler velocimetry abnormalities. SGA infants may constitute intrauterine growth restricted as well as constitutionally small infants. This distinction can be made more accurately by complementary assessment of body composition. The clinical meaning of each group identified by body composition will be assessed by the evolution until 3-months of age. The feeding pattern and composition will be considered a major postnatal exposure. Accurate classification of IUGR profiles is essential to ensure appropriate nutritional intervention.
Official title: Determination of Clinical Phenotypes of Intrauterine Growth Restriction in Term Infants Based on Body Composition. A Potential Contribution to Nutritional Management.
Key Details
Gender
All
Age Range
37 Weeks - 41 Weeks
Study Type
OBSERVATIONAL
Enrollment
290
Start Date
2025-11-19
Completion Date
2028-06-30
Last Updated
2026-04-02
Healthy Volunteers
Yes
Conditions
Interventions
Small for gestational age (SGA) infants
* Body composition assessment will be conducted using a Displacement Plethysmograph (Pea Pod, Cosmed, Italy), which is validated for newborns (Ellis et al., 2007). Subsequent assessments will be performed by the same observer at 1 week after discharge, 1 month and 3 months of age. * At birth and during body composition evaluations, anthropometric measurements (body weight, length and head circumference) will be measured. * The breast milk macronutrient and energy content will be analyzed using the Miris® Human Milk analyzer (Miris AB, Uppsala, Sweden). Mothers will be asked to save, once a week, circa 4 cc of midfeeding breast milk during the noon feeding, as a systematic sampling of milk collected through 24 hours, in order to bring the conditions for expressing milk closer together for all mothers.
Adequate for gestational age (AGA) infants
* Body composition assessment will be conducted using a Displacement Plethysmograph (Pea Pod, Cosmed, Italy), which is validated for newborns (Ellis et al., 2007). Subsequent assessments will be performed by the same observer at 1 week after discharge, 1 month and 3 months of age. * At birth and during body composition evaluations, anthropometric measurements (body weight, length and head circumference) will be measured. * The breast milk macronutrient and energy content will be analyzed using the Miris® Human Milk analyzer (Miris AB, Uppsala, Sweden). Mothers will be asked to save, once a week, circa 4 cc of midfeeding breast milk during the noon feeding, in order to bring the conditions for expressing milk closer together for all mothers.
Locations (1)
Unidade Local de Saúde São José
Lisbon, Portugal