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Clinical Trials in Portugal / NCT07483424
Enrolling by invitation Observational

Determination of Clinical Phenotypes of Intrauterine Growth Restriction in Term Infants Based on Body Composition

NCT07483424 · tracked via the Priya Life Science Portugal tracker
Phase
Observational
Started
2025-11-19
Last updated
2026-04-02

Condition(s) studied

Intrauterine Growth Restriction (IUGR)

Investigational drug(s) / intervention(s)

Small for gestational age (SGA) infantsAdequate for gestational age (AGA) infants

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.

Study 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.

Eligibility

Sex
ALL
Min age
37 Weeks
Max age
41 Weeks
Healthy volunteers
Accepted
Inclusion Criteria: * IUGR and term GA (37+0/7 to 41+6/7 weeks of gestation) Exclusion Criteria: * Eligible fetuses with congenital malformations * Eligible fetuses with genetic mutations. * Eligible infants with congenital malformations * Eligible intants with inborn errors of metabolism. * Infants who become ill and require hospitalization during the study period * Infants who die during the study period * Parents or legal guardians who do not agree to participate * Parents or legal guardians who abandon the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Unidade Local de Saúde São José Lisbon Portugal

More Centro Hospitalar de Lisboa Central trials in Portugal

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07483424 on ClinicalTrials.gov ↗ ← All trials in Portugal