Intrauterine Growth Restriction (IUGR)RestrigrowthNCT07483424
Determination of Clinical Phenotypes of Intrauterine Growth Restriction in Term Infants Based on Body Composition
An observational study of Intrauterine Growth Restriction (IUGR), run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 41 weeksHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Growth Restriction (IUGR)
- What is being tested?
- Small for gestational age (SGA) infants and Adequate for gestational age (AGA) infants
- How many people
- 290 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Nov 2025to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 41 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Full term infants diagnosed with intrauterine growth restriction.
Who may be able to join
- IUGR and term GA (37+0/7 to 41+6/7 weeks of gestation)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Determination of Clinical Phenotypes of Intrauterine Growth Restriction in Term Infants Based on Body Composition. A Potential Contribution to Nutritional Management.
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.
Read the detailed description
Study design: This is a single-center prospective observational, cohort study of full-term infants born with intrauterine growth restriction (IUGR) and their lactating mothers.
Study period: A consecutive recruitment of participants will be conducted over 18 months (from November 19, 2025). Eligible children, whose parents accepted the invitation to participate, will be recruited in a follow-up study until they are 3 months old.
Settings: Neonatology Unit, Prenatal Diagnostic Center and Human Milk Bank at Maternidade Dr. Alfredo da Costa, Unidade Local de Saúde São José, Lisbon. Nutrition Laboratory of Hospital Dona Estefânia, Unidade Local de Saúde São José, Lisbon, Portugal.
Variables in study:
- Mother's retrieved demographic and clinical variables will include: mother's age, height, reported body weight closer to the beginning of pregnancy, body weight gain during pregnancy, pathological conditions during pregnancy (diabetes mellitus type I and type II, gestational diabetes, gestational hypertension, hypertension, pre-eclampsia, chronic renal disease, systemic lupus erythematosus, anaemia or other conditions).
- Obstetrics' Doppler velocimetry serial ultrasounds will be analysed. The data retrieved will include gestational age at ultrasound date, fetal abdominal circumference, femur length, head circumference, estimated fetal weight, pulsatility index of umbilical artery, middle cerebral artery, venous duct and uterine artery.
- Mothers dietary habits: A semi-quantitative food frequency questionnaire consisting of 86 food items, validated for Portuguese pregnant women, will be applied one week after birth to assess food intake during the second and third trimesters of pregnancy.
- Breast milk macronutrient and energy content: 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 circa 4 cc of midfeeding breast milk during the noon feeding, as a systematic sampling of milk collected through 24 hours, in order to minimize daily variability of breast milk composition. Before each use, the analyzer will be calibrated using the standard calibration solution. The breast milk composition will be expressed in densities: Kcal/dL of energy and g/dL of fat, total and true protein, carbohydrates, and ashes.
- Neonatal variables: gestational age at birth, sex, parity, birth weight, height and head circumference, gestational age adequacy.
- Body composition assessment: Body composition assessment will be conducted using a Displacement Plethysmograph (Pea Pod, Cosmed, Italy), which is validated for newborns. Subsequent assessments will be performed by the same observer at 1 week after discharge, 1 month and 3 months of age (+/- 1 week). The equipment automatically provides fat mass (FM), fat-free mass (FFM) and fat mass percentage (%FM). The same observer will measure length, and this measurement will be used to calculate the fat mass index (FMI). Adiposity will be defined by %FM (FM (kg)/body mass (kg)) and FMI (FM (kg)/length (m²)).
Estimate of sample size: Assuming the highest probability (2:1) of reduced adiposity in small-for-gestational-age (SGA) infants with reduced fat-free mass (FFM), SGA infants with reduced adiposity, appropriate-for-gestational-age (AGA) infants with fetal growth deceleration and/or Doppler velocimetry abnormalities with reduced FFM, and AGA infants with fetal growth deceleration and/or Doppler velocimetry abnormalities with reduced adiposity, and considering a 95% confidence interval, the expected sample size is 145 SGA infants and 145 AGA infants.
Comparison groups: Body composition will be compared between the following IUGR profiles: SGA infants without fetal growth deceleration or Doppler velocimetry abnormalities; SGA with fetal growth deceleration or Doppler velocimetry abnormalities; AGA with fetal growth deceleration or Doppler velocimetry abnormalities; SGA with reduced FFM (Fat-free-mass); SGA with reduced adiposity; AGA with fetal growth deceleration and/or Doppler velocimetry abnormalities with reduced FFM. AGA with fetal growth deceleration and/or Doppler velocimetry abnormalities with reduced adiposity.
- Conditions
- Intrauterine Growth Restriction (IUGR)
- Being tested
- Small for gestational age (SGA) infants, Adequate for gestational age (AGA) infants
- Keywords
- Doppler velocimetry, fetal growth, intrauterine growth restriction, nutritional management, small for gestational age
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small for gestational age (SGA) infantsDietary 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.
Adequate for gestational age (AGA) infantsDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Adequate for gestational age (AGA) infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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 (%)
Measured: Adiposity will be assessed 1 week after discharge, 1 month of age and 3 months of age
Secondary outcomes (13)
Neonatal anthropometry - Body weight
Body weight will be measured using a calibrated neonatal scale. Unit of measure: Kilograms (kg)
Measured: At birth, 1 week after discharge, 1 month of age and 3 months of age
Neonatal anthropometry - Length
Length will be measured using an infantometer. Unit of measure: Centimeter (cm)
Measured: 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 using a non-stretchable measuring tape. Unit of measure: Centimeter (cm)
Measured: Head circumference will be measured at birth, 1 week after discharge, 1 month of age and 3 months of age
Breast milk energy content
Energy content of breast milk will be measured 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.
Unit of measure: kcal/dL
Measured: Weekly from birth until 3 months of age
Breast milk macronutrient concentration
Breast milk macronutrient concentrations, including raw protein, true protein, fat, carbohydrates and ashes will be measured 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.
Unit of measure: g/dL
Measured: Weekly from birth until 3 months of age
Mothers dietary habits - Mother energy intake
Maternal dietary intake during the second and third trimesters of pregnancy will be assessed using a semi-quantitative food frequency questionnaire validated for Portuguese pregnant women. Reported frequencies and standard portion sizes will be converted to estimated energy intake.
Unit of measure: kcal/day
Measured: Assessed once at recruitment, within the first week after birth
Maternal dietary habits - Maternal macronutrient intake
Maternal intake of protein, fat, and carbohydrates during the second and third trimesters of pregnancy will be estimated using a semi-quantitative Food Frequency Questionnaire validated for Portuguese pregnant women. Reported food frequencies and portion sizes will be converted into estimated daily macronutrient intake.
Unit of measure: g/day
Measured: Assessed once at recruitment, within the first week after birth
Prenatal fetal biometry and Doppler percentiles
Prenatal fetal biometry and Doppler measurements will be retrieved from obstetric ultrasound records and recorded as percentiles for gestational age, according to the reference standards used in the clinical ultrasound reports. Parameters will include abdominal circumference, femur length, head circumference, estimated fetal weight, and pulsatility index percentiles for the umbilical artery, middle cerebral artery, ductus venosus, and uterine arteries.
Unit of Measure: Percentile
Measured: Assessed retrospectively during the study period
Maternal demographic and clinical variables - Maternal age
Maternal age will be determined from the maternal date of birth recorded in clinical records or reported at recruitment.
Unit of Measure: Years
Measured: At birth (time of recruitment)
Mother's demographic and clinical variables - Maternal height
Maternal height will be retrieved from clinical records or reported by the mother at recruitment.
Unit of Measure: Meters (m)
Measured: At birth (time of recruitment)
Mother's demographic and clinical variables - Pre-pregnancy weight
Maternal pre-pregnancy weight will be retrieved from clinical records or reported by the mother at recruitment.
Unit of Measure: Kilograms (kg)
Measured: At birth (time of recruitment)
Mother's demographic and clinical variables - Postpartum weight
Maternal postpartum weight will be reported by the mother during follow-up. Unit of Measure: Kilograms (kg)
Measured: From recruitment until 3 months after birth
Mother's demographic and clinical variables - Pregnancy related medical conditions
Pregnancy-related medical conditions will be retrieved from clinical records, including diabetes mellitus (type 1 or type 2), gestational diabetes, gestational hypertension, pre-eclampsia, chronic renal disease, systemic lupus erythematosus, and anaemia.
Unit of Measure: Presence or absence of condition
Measured: Assessed retrospectively during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start19 Nov 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Growth Restriction (IUGR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Lisboa Central
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuela Cardoso, RDN, PhD, Principal investigator, Unidade Local de Saude Sao Jose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483424
- Sponsor's protocol ID
- CHULC.CI.658.2026
- Acronym
- Restrigrowth
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20624208Goswami 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.
PubMed 27399768Ellis 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.
PubMed 17209182Cardoso 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.
PubMed 36986263Cardoso 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.
PubMed 33477964Czosnykowska-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.
PubMed 30513944
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Clinical Phenotypes of Intrauterine Growth Restriction in Term Infants Based on Body Composition. A Potential Contribution to Nutritional Management.
- ClinicalTrials.gov ID
- NCT07483424
- Acronym / sponsor ID
- Restrigrowth / CHULC.CI.658.2026
- Conditions
- Intrauterine Growth Restriction (IUGR)
- Keywords
- Doppler velocimetry, fetal growth, intrauterine growth restriction, nutritional management, small for gestational age
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Centro Hospitalar de Lisboa CentralUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design: This is a single-center prospective observational, cohort study of full-term infants born with intrauterine growth restriction (IUGR) and their lactating mothers.
Study period: A consecutive recruitment of participants will be conducted over 18 months (from November 19, 2025). Eligible children, whose parents accepted the invitation to participate, will be recruited in a follow-up study until they are 3 months old.
Settings: Neonatology Unit, Prenatal Diagnostic Center and Human Milk Bank at Maternidade Dr. Alfredo da Costa, Unidade Local de Saúde São José, Lisbon. Nutrition Laboratory of Hospital Dona Estefânia, Unidade Local de Saúde São José, Lisbon, Portugal.
Variables in study:
- Mother's retrieved demographic and clinical variables will include: mother's age, height, reported body weight closer to the beginning of pregnancy, body weight gain during pregnancy, pathological conditions during pregnancy (diabetes mellitus type I and type II, gestational diabetes, gestational hypertension, hypertension, pre-eclampsia, chronic renal disease, systemic lupus erythematosus, anaemia or other conditions).
- Obstetrics' Doppler velocimetry serial ultrasounds will be analysed. The data retrieved will include gestational age at ultrasound date, fetal abdominal circumference, femur length, head circumference, estimated fetal weight, pulsatility index of umbilical artery, middle cerebral artery, venous duct and uterine artery.
- Mothers dietary habits: A semi-quantitative food frequency questionnaire consisting of 86 food items, validated for Portuguese pregnant women, will be applied one week after birth to assess food intake during the second and third trimesters of pregnancy.
- Breast milk macronutrient and energy content: 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 circa 4 cc of midfeeding breast milk during the noon feeding, as a systematic sampling of milk collected through 24 hours, in order to minimize daily variability of breast milk composition. Before each use, the analyzer will be calibrated using the standard calibration solution. The breast milk composition will be expressed in densities: Kcal/dL of energy and g/dL of fat, total and true protein, carbohydrates, and ashes.
- Neonatal variables: gestational age at birth, sex, parity, birth weight, height and head circumference, gestational age adequacy.
- Body composition assessment: Body composition assessment will be conducted using a Displacement Plethysmograph (Pea Pod, Cosmed, Italy), which is validated for newborns. Subsequent assessments will be performed by the same observer at 1 week after discharge, 1 month and 3 months of age (+/- 1 week). The equipment automatically provides fat mass (FM), fat-free mass (FFM) and fat mass percentage (%FM). The same observer will measure length, and this measurement will be used to calculate the fat mass index (FMI). Adiposity will be defined by %FM (FM (kg)/body mass (kg)) and FMI (FM (kg)/length (m²)).
Estimate of sample size: Assuming the highest probability (2:1) of reduced adiposity in small-for-gestational-age (SGA) infants with reduced fat-free mass (FFM), SGA infants with reduced adiposity, appropriate-for-gestational-age (AGA) infants with fetal growth deceleration and/or Doppler velocimetry abnormalities with reduced FFM, and AGA infants with fetal growth deceleration and/or Doppler velocimetry abnormalities with reduced adiposity, and considering a 95% confidence interval, the expected sample size is 145 SGA infants and 145 AGA infants.
Comparison groups: Body composition will be compared between the following IUGR profiles: SGA infants without fetal growth deceleration or Doppler velocimetry abnormalities; SGA with fetal growth deceleration or Doppler velocimetry abnormalities; AGA with fetal growth deceleration or Doppler velocimetry abnormalities; SGA with reduced FFM (Fat-free-mass); SGA with reduced adiposity; AGA with fetal growth deceleration and/or Doppler velocimetry abnormalities with reduced FFM. AGA with fetal growth deceleration and/or Doppler velocimetry abnormalities with reduced adiposity.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small for gestational age (SGA) infants | – | Dietary Supplement: Small for gestational age (SGA) infantsFull-term SGA infants are defined by a birth weight below the 3rd percentile on the Fenton et al. (2025) growth charts. |
| Adequate for gestational age (AGA) infants | – | Dietary Supplement: Adequate for gestational age (AGA) infantsFull-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. |
Who may qualify
- Ages
- 37 to 41 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Full term infants diagnosed with intrauterine growth restriction.
Key inclusion criteria (1 listed)
- IUGR and term GA (37+0/7 to 41+6/7 weeks of gestation)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Small for gestational age (SGA) infants |
| 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. | Dietary supplement | Adequate for gestational age (AGA) infants |
Primary outcome
Body composition assessment - Fat mass (FM)
Time frame: Fat mass will be assessed 1 week after discharge, 1 month of age and 3 months of age
Fat mass will be assessed using air-displacement plethysmography (Pea Pod, Cosmed, Italy) and expressed in kilograms. Unit of measure: Kilograms (kg)
Body composition assessment - Fat-free mass (FFM)
Time frame: Fat-free mass will be assessed 1 week after discharge, 1 month of age and 3 months of age
Body composition will be assessed using air-displacement plethysmography (Pea Pod, Cosmed, Italy) and expressed in kilograms. Unit of measure: Kilograms (kg)
Body composition assessment - Fat mass index (FMI)
Time frame: Fat mass index will be calculated 1 week after discharge, 1 month of age and 3 months of age
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
Body composition assessment - Adiposity (%FM)
Time frame: Adiposity will be assessed 1 week after discharge, 1 month of age and 3 months of age
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 (%)
13 secondary outcomes
Neonatal anthropometry - Body weight
Time frame: At birth, 1 week after discharge, 1 month of age and 3 months of age
Neonatal anthropometry - Length
Time frame: Length will be measured at birth, 1 week after discharge, 1 month of age and 3 months of age
Neonatal anthropometry - Head circumference
Time frame: Head circumference will be measured at birth, 1 week after discharge, 1 month of age and 3 months of age
Breast milk energy content
Time frame: Weekly from birth until 3 months of age
Breast milk macronutrient concentration
Time frame: Weekly from birth until 3 months of age
Mothers dietary habits - Mother energy intake
Time frame: Assessed once at recruitment, within the first week after birth
Maternal dietary habits - Maternal macronutrient intake
Time frame: Assessed once at recruitment, within the first week after birth
Prenatal fetal biometry and Doppler percentiles
Time frame: Assessed retrospectively during the study period
Maternal demographic and clinical variables - Maternal age
Time frame: At birth (time of recruitment)
Mother's demographic and clinical variables - Maternal height
Time frame: At birth (time of recruitment)
Mother's demographic and clinical variables - Pre-pregnancy weight
Time frame: At birth (time of recruitment)
Mother's demographic and clinical variables - Postpartum weight
Time frame: From recruitment until 3 months after birth
Mother's demographic and clinical variables - Pregnancy related medical conditions
Time frame: Assessed retrospectively during the study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 20624208Pinto 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.
- Background: PubMed 27399768Goswami 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.
- Background: PubMed 17209182Ellis 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.
- Background: PubMed 36986263Cardoso 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.
- Background: PubMed 33477964Cardoso 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.
- Background: PubMed 30513944Czosnykowska-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manuela Cardoso, RDN, PhD principal investigator
Unidade Local de Saude Sao Jose
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction (IUGR), run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition assessment - Fat mass (FM) (time frame: Fat mass will be assessed 1 week after discharge, 1 month of age and 3 months of age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07483424, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.