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

NCT07483424 | Enrolling By Invitation

• 1 other identifier: CHULC.CI.658.2026
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intrauterine Growth Restriction (IUGR)

Keywords

Doppler velocimetry; fetal growth; intrauterine growth restriction; nutritional management; small for gestational age

Outcome Measures

Primary Outcomes (4)

• Body composition assessment - Fat mass (FM)

  Fat mass will be assessed using air-displacement plethysmography (Pea Pod, Cosmed, Italy) and expressed in kilograms. Unit of measure: Kilograms (kg)

  Fat mass will be assessed 1 week after discharge, 1 month of age and 3 months of age

• Body composition assessment - Fat-free mass (FFM)

  Body composition will be assessed using air-displacement plethysmography (Pea Pod, Cosmed, Italy) and expressed in kilograms. Unit of measure: Kilograms (kg)

  Fat-free mass will be assessed 1 week after discharge, 1 month of age and 3 months of age

• Body composition assessment - Fat mass index (FMI)

  Fat mass index (FMI) will be calculated by dividing fat mass (kg), obtained from air-displacement plethysmography, by length squared (m²). Formula: FMI (kg/m²) = fat mass (kg) / \[length (m)\]² Unit of Measure: kg/m²

  Fat mass index will be calculated 1 week after discharge, 1 month of age and 3 months of age

• Body composition assessment - Adiposity (%FM)

  Adiposity will be assessed as fat mass percentage (%FM). Fat mass will be measured using air-displacement plethysmography (Pea Pod, Cosmed, Italy), and adiposity will be calculated as: %FM = \[fat mass (kg) / body weight (kg)\] × 100 Unit of Measure: Percentage (%)

  Adiposity will be assessed 1 week after discharge, 1 month of age and 3 months of age

Secondary Outcomes (13)

• Neonatal anthropometry - Body weight

  At birth, 1 week after discharge, 1 month of age and 3 months of age

• Neonatal anthropometry - Length

  Length will be measured at birth, 1 week after discharge, 1 month of age and 3 months of age

• Neonatal anthropometry - Head circumference

  Head circumference will be measured at birth, 1 week after discharge, 1 month of age and 3 months of age

• Breast milk energy content

  Weekly from birth until 3 months of age

• Breast milk macronutrient concentration

  Weekly from birth until 3 months of age

Study Arms (2)

Small for gestational age (SGA) infants

Full-term SGA infants are defined by a birth weight below the 3rd percentile on the Fenton et al. (2025) growth charts.

Dietary Supplement: Small for gestational age (SGA) infants

Adequate for gestational age (AGA) infants

Full-term AGA infants are defined by a birth weight equal to or above the 3rd percentile on the curves of Fenton et al. (2025), and are associated with intrauterine growth restriction and/or Doppler velocimetry abnormalities.

Dietary Supplement: Adequate for gestational age (AGA) infants

Interventions

Small for gestational age (SGA) infants DIETARY_SUPPLEMENT

* 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.

Small for gestational age (SGA) infants

Adequate for gestational age (AGA) infants DIETARY_SUPPLEMENT

* 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.

Adequate for gestational age (AGA) infants

Eligibility Criteria

• Age: 37 Weeks - 41 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Full term infants diagnosed with intrauterine growth restriction.

You may qualify if:

• IUGR and term GA (37+0/7 to 41+6/7 weeks of gestation)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Hospitalar de Lisboa Central: lead

Study Sites (1)

Unidade Local de Saúde São José

Lisbon, 1150-199, Portugal

Location

Related Publications (6)

• Pinto E, Severo M, Correia S, dos Santos Silva I, Lopes C, Barros H. Validity and reproducibility of a semi-quantitative food frequency questionnaire for use among Portuguese pregnant women. Matern Child Nutr. 2010 Apr;6(2):105-19. doi: 10.1111/j.1740-8709.2009.00199.x.

  PMID: 20624208 BACKGROUND

• Goswami I, Rochow N, Fusch G, Liu K, Marrin ML, Heckmann M, Nelle M, Fusch C. Length Normalized Indices for Fat Mass and Fat-Free Mass in Preterm and Term Infants during the First Six Months of Life. Nutrients. 2016 Jul 8;8(7):417. doi: 10.3390/nu8070417.

  PMID: 27399768 BACKGROUND

• Ellis KJ, Yao M, Shypailo RJ, Urlando A, Wong WW, Heird WC. Body-composition assessment in infancy: air-displacement plethysmography compared with a reference 4-compartment model. Am J Clin Nutr. 2007 Jan;85(1):90-5. doi: 10.1093/ajcn/85.1.90.

  PMID: 17209182 BACKGROUND

• Cardoso M, Virella D, Papoila AL, Alves M, Macedo I, E Silva D, Pereira-da-Silva L. Individualized Fortification Based on Measured Macronutrient Content of Human Milk Improves Growth and Body Composition in Infants Born Less than 33 Weeks: A Mixed-Cohort Study. Nutrients. 2023 Mar 22;15(6):1533. doi: 10.3390/nu15061533.

  PMID: 36986263 BACKGROUND

• Cardoso M, Virella D, Macedo I, Silva D, Pereira-da-Silva L. Customized Human Milk Fortification Based on Measured Human Milk Composition to Improve the Quality of Growth in Very Preterm Infants: A Mixed-Cohort Study Protocol. Int J Environ Res Public Health. 2021 Jan 19;18(2):823. doi: 10.3390/ijerph18020823.

  PMID: 33477964 BACKGROUND

• Czosnykowska-Lukacka M, Krolak-Olejnik B, Orczyk-Pawilowicz M. Breast Milk Macronutrient Components in Prolonged Lactation. Nutrients. 2018 Dec 3;10(12):1893. doi: 10.3390/nu10121893.

  PMID: 30513944 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast milk from mothers

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Gestational Age

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fetal Development; Embryonic and Fetal Development; Morphogenesis; Growth and Development; Physiological Phenomena; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Manuela Cardoso, RDN, PhD

  Unidade Local de Saúde São José

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 19, 2026
• Study Start: November 19, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

PT (1)