GrowthNCT01721512
The Growth and Development of Breast and Formula Fed Term Asian Infants
An observational study of Growth, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia Read more about this study
- Who is it for?
- Ages 2 to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Breastfeeding and Infant formula
- How many people
- 160 participants
- Where
- 1 siteIndonesia
- Study dates
- Sep 2010to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy infants recruited from Jati Padang, Pasar Minggu District, South Jakarta, Indonesia
Who may be able to join
- Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4 months; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg.
- Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial infant formula for 12 months.
Who cannot join
- 1. Severe congenital or metabolic disease likely to affect infant feeding or infant growth.
- 2. Multiple birth
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Indonesia
Jakarta, Jakarta Special Capital Region, 10430
About this study
Official title: The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.
Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia
- Conditions
- Growth
- Being tested
- Breastfeeding, Infant formula
- Keywords
- Prospective observational study, Breast feeding, Infant formula, Infant, Indonesia
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastfeedingOther
Infant formulaOther
| Study group | Role | What they receive |
|---|---|---|
| Breast-fed infants | 80 infants of mothers who plan to exclusively breastfeed for at least 6 months. Receives: Other: Breastfeeding | |
| Formula-fed infants | 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding.
2. Mother consents to her infant receiving trial infant formula for 12 months Receives: Other: Infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant weight, body length head circumference
Infant weight, body length head circumference at enrolment, 2 weeks, 4 weeks and monthly thereafter until 6 months, and then at 8, 10 and 12 months.
Measured: 12 months
Secondary outcomes (6)
Gastrointestinal tolerance
Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months
Measured: 6 months
Indicators or formula tolerance
Indicators or formula tolerance: crying, irritability, sleep patterns
Measured: 12 months
General health
General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage
Measured: 12 months
Gut integrity
Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin
Measured: 3 months
Gut microflora
Gut microflora: real time PCR
Measured: 3 months
Developmental progress
Developmental progress: assessed by Ages and Stages
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GrowthStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Fonterra Brands (Singapore) PTE LTD
- Responsible party
- Principal investigator, Prof. Agus Firmansyah, MD, Ph.D, Universitas Indonesia
- Investigators
- Agus Firmansyah, Professor, MD, PhD, SpA(K), Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721512
- Sponsor's protocol ID
- Project Grow
- Status last verified
- Nov 2012
- First submitted
- 1 Nov 2012
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dwipoerwantoro PG, Mansyur M, Oswari H, Makrides M, Cleghorn G, Firmansyah A. Growth of Indonesian Infants Compared With World Health Organization Growth Standards. J Pediatr Gastroenterol Nutr. 2015 Aug;61(2):248-52. doi: 10.1097/MPG.0000000000000770.
PubMed 25710823
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.
- ClinicalTrials.gov ID
- NCT01721512
- Acronym / sponsor ID
- Project Grow
- Conditions
- Growth
- Keywords
- Prospective observational study, Breast feeding, Infant formula, Infant, Indonesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Fonterra Brands (Singapore) PTE LTD
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 5 Nov 2012 (estimated)
- 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.
Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast-fed infants | – | Other: Breastfeeding80 infants of mothers who plan to exclusively breastfeed for at least 6 months. |
| Formula-fed infants | – | Other: Infant formula1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding. 2. Mother consents to her infant receiving trial infant formula for 12 months |
Who may qualify
- Ages
- 2 to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy infants recruited from Jati Padang, Pasar Minggu District, South Jakarta, Indonesia
Key inclusion criteria (2 listed)
- Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4 months; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg.
- Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial infant formula for 12 months.
Key exclusion criteria (2 listed)
- 1. Severe congenital or metabolic disease likely to affect infant feeding or infant growth.
- 2. Multiple birth
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 |
|---|---|---|
| Breastfeeding | Other | Breast-fed infants |
| Infant formula | Other | Formula-fed infants |
Primary outcome
Infant weight, body length head circumference
Time frame: 12 months
Infant weight, body length head circumference at enrolment, 2 weeks, 4 weeks and monthly thereafter until 6 months, and then at 8, 10 and 12 months.
6 secondary outcomes
Gastrointestinal tolerance
Time frame: 6 months
Indicators or formula tolerance
Time frame: 12 months
General health
Time frame: 12 months
Gut integrity
Time frame: 3 months
Gut microflora
Time frame: 3 months
Developmental progress
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2012.
- Derived from this study: PubMed 25710823Dwipoerwantoro PG, Mansyur M, Oswari H, Makrides M, Cleghorn G, Firmansyah A. Growth of Indonesian Infants Compared With World Health Organization Growth Standards. J Pediatr Gastroenterol Nutr. 2015 Aug;61(2):248-52. doi: 10.1097/MPG.0000000000000770.
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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. This study is not recruiting at the moment.
Agus Firmansyah, Professor, MD, PhD, SpA(K) principal investigator
Universitas Indonesia
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 Growth, run by Universitas Indonesia at 1 site in Indonesia.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 5 Nov 2012. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Infant weight, body length head circumference (time frame: 12 months). 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 NCT01721512, which also lists 1 linked publication.
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 5 Nov 2012.