An observational study in Infant, Small for Gestational Age, Body Composition and Infant Growth, sponsored by Shoklo Malaria Research Unit. Not yet recruiting at 1 site in Thailand. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Shoklo Malaria Research Unit · Observational
Birth weight alone is not precise enough to explain the nutritional status of a newborn baby. For SGA babies (born smaller than they should be for birth age and sex) a sophisticated machine called a PEAPOD can calculate the percentage of body fat, fat mass and fat-free mass. The PEAPOD does these measurements by moving air around a baby placed on a scale inside a Pod. The procedure is quick (average 7 minutes), accurate, safe and useful to 6 months of age. The investigators want to understand if there are clues in the body composition of babies born to small compared to babies of the right size that point to why born too small have increased risk of heart and blood vessel problems linked to issues like diabetes and obesity, later in life. A type of study called "matched case-control" could help us investigate mother factors that are associated with being born too small. Cases (SGA) will be matched with controls (AGA, a baby born not too small and not too large) based on sex, weeks of age at birth (±1 week), number of births the mother has had (same parity). Information about the study will be given in pregnancy. If consent is provided blood samples (mother and cord) will be collected at birth. Small amount of blood will be taken from mother and baby one time at birth, 1, 2, 3, 4, 5 and 6 months; and babies will attend for 7 PEAPOD measurements unless birth weight >6.0kg is reached first. Additionally, mother's breast milk will be collected. These will be used to measure different molecules in the blood related to health and disease. With the data from this study, the investigators may be able to provide better recommendations during pregnancy that can help optimize baby and infant nutritional status and adult health outcomes.
This study aims to investigate body composition at birth and its evolution over the first six months of life in neonates using air-displacement plethysmography (PEAPOD). Traditional anthropometric measures such as birth weight and length provide limited information on neonatal nutritional status, as they do not distinguish between fat mass and fat-free mass. Understanding early body composition may offer important insights into infant growth patterns and long-term health outcomes, including risks of metabolic and cardiovascular diseases.
This is a prospective longitudinal matched case-control study conducted at the Mawker Thai Clinic, Shoklo Malaria Research Unit (SMRU), along the Thailand-Myanmar border. The study will recruit 300 mother-infant pairs, including 150 small-for-gestational-age (SGA) neonates and 150 appropriate-for-gestational-age (AGA) neonates. Cases and controls will be matched based on sex, gestational age (±1 week), and parity.
Following informed consent obtained during pregnancy, baseline maternal data will be collected from routine antenatal care. After delivery, neonatal eligibility will be confirmed, and study procedures will begin within 24-48 hours of birth. Body composition measurements will be performed using the PEAPOD device, a validated, non-invasive method for assessing fat mass, fat-free mass, and percentage body fat in infants.
Participants will be followed monthly up to six months postpartum (or until the infant reaches 6.0 kg, the upper limit for PEAPOD measurement). At each visit, both maternal and infant assessments will be conducted. These include anthropometric measurements, body composition assessments, and collection of biological samples such as maternal venous blood, umbilical cord blood, capillary blood samples, and maternal breast milk. Laboratory analyses will include haematological parameters and nutritional biomarkers relevant to maternal and infant health.
The primary objective is to compare longitudinal changes in body composition between SGA and AGA infants during the first six months of life. Secondary objectives include identifying maternal and fetal factors associated with neonatal and infant body composition, including maternal nutritional status, gestational weight gain, metabolic conditions, and breast milk composition.
This study will provide important evidence on early-life body composition trajectories in a resource-limited setting and may inform strategies to improve maternal and infant health, nutritional interventions, and long-term disease prevention.
Shoklo Malaria Research Unit is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant woman attending for antenatal care or admitted for delivery and their neonates attending at Mawker Thai clinic along the Thailand-Myanmar border. The study population includes both small for gestational age (SGA) and appropriate for gestational age (AGA) neonates and their mothers, representing a resource-limited border population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnant woman
Neonates
Normal, single-baby pregnancy (singleton) born at term at Mawker Thai clinic.
Exclusion Criteria:
Pregnant woman
Baby born requiring admission to the special care baby unit (SCBU).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neonates classified as small for gestational age (SGA), defined as birth weight below the 10th percentile for gestational age. Participants will undergo non-invasive body composition measurements using air-displacement plethysmography (PEAPOD) and follow-up assessments at monthly intervals up to six months of age (or until reaching 6.0 kg). Additional study procedures include anthropometric measurements and collection of biological samples (maternal blood, cord blood, infant capillary blood, and breast milk) for laboratory analyses.
Device: PEAPOD Air Displacement Plethysmography Device
Neonates classified as appropriate for gestational age (AGA), defined as birth weight between the 10th and 90th percentile for gestational age. Participants will undergo the same study procedures as the SGA group, including non-invasive body composition measurements using PEAPOD and follow-up assessments at monthly intervals up to six months of age (or until reaching 6.0 kg), along with anthropometric measurements and collection of biological samples for laboratory analyses.
Device: PEAPOD Air Displacement Plethysmography Device
The PEAPOD air displacement plethysmography system is a non-invasive device used to measure infant body composition, including fat mass, fat-free mass, and percentage body fat. The measurement is performed by placing the infant in a calibrated chamber for a short duration, during which body volume and mass are assessed. The procedure is safe, painless, and does not involve radiation or invasive techniques. In this study, the device is used solely for observational measurement of body composition and not as a therapeutic intervention.
Also known as: PEAPOD Infant Body Composition Device
Body composition changes - Fat mass in neonates with small for gestational age (SGA) and appropriate for gestational age (AGA) at birth and during the first 6 months of life
Fat mass (kg) measured using air displacement plethysmography (PEAPOD) at birth and during follow-up visits to compare between small for gestational age (SGA) and appropriate for gestational age (AGA) infants
Time frame: At birth, 1, 2, 3, 4, 5 and 6 months of life (unless body weight >6.0kg is reached first)
Body composition changes - Fat-free mass in neonates with small for gestational age (SGA) and appropriate for gestational age (AGA) at birth and during the first 6 months of life
Fat-free mass (kg) measured using PEAPOD at birth and during follow-up visits to compare between SGA and AGA infants
Time frame: At birth, 1, 2, 3, 4, 5 and 6 months of life (unless body weight >6.0kg is reached first)
Percentage body fat in SGA and AGA infants
Percentage body fat (%) measured using PEAPOD at birth and during follow-up visits to compare between SGA and AGA infants
Time frame: At birth, 1, 2, 3, 4, 5 and 6 months of life (unless body weight >6.0kg is reached first)
Maternal First-Trimester Body Mass Index (BMI)
Maternal first-trimester BMI (kg/m²) calculated from weight and height recorded during antenatal care
Time frame: Baseline (antenatal records)
Maternal Gestational Weight Gain
Maternal gestational weight gain (kg) calculated from antenatal weight measurements
Time frame: Baseline (antenatal records)
Gestational Diabetes Mellitus Status
Presence or absence of gestational diabetes mellitus documented in maternal clinical records
Time frame: Baseline (antenatal records)
Maternal Anaemia
Presence or absence of maternal anaemia determined from maternal haemoglobin measurements
Time frame: Baseline to maximum 6 months postpartum
Maternal HbA1c Concentration
Maternal glycated haemoglobin (HbA1c) percentage (%) measured from maternal blood samples
Time frame: Delivery and 2 months postpartum
Breast Milk Creamatocrit
Creamatocrit percentage (%) measured from maternal breast milk samples
Time frame: At birth to maximum 6 months postpartum
Breast Milk Sodium Concentration
Sodium concentration (mmol/L) measured from maternal breast milk samples
Time frame: At birth to maximum 6 months postpartum
Breast Milk Proteomic Profile
Proteomic profile of maternal breast milk measured using MALDI-TOF analysis
Time frame: Delivery and monthly postpartum until 6 months
Plan to share: No — Individual participant data (IPD), including de-identified clinical, anthropometric, laboratory, and body composition data collected during the study, will not be made publicly available. Data collected in this study involve sensitive information from mothers and neonates in a vulnerable population, and sharing will be restricted to protect participant confidentiality. De-identified data may be made available upon reasonable request, subject to review and approval by the study investigators and relevant institutional authorities, and in accordance with data sharing agreements and applicable ethical and regulatory requirements.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Oct 2028, 22 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shoklo Malaria Research Unit