Infant NewbornNCT01300000
Effects of Early Nutrition on Growth
A study testing Human Milk, Investigational infant formula and Milk based standard infant formula in people with Infant Newborn, run by Abbott Nutrition at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula. Read more about this study
- Who is it for?
- Ages 1 minute to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Infant Newborn
- What is being tested?
- Human Milk, Investigational infant formula and Milk based standard infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 649 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Aug 2016
- Phase
- Interventional
- 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 1 minute to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- good health
- singleton birth with gestational age 37-42 weeks
- infant's birth weight >or = to 2500 grams
- exclusive breastfeeding or exclusively formula feeding
- within a defined geographical boundary
- mother has no problems communicating in English
Who cannot join
- adverse maternal, fetal or infant medical history
- congenital disease or malformation affecting growth or development
- illness or social problems in mother or infant
- temporary residents
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MRC Childhood Nutrition Research Center, Institute of Child Health
London
About this study
Official title: Effects of Early Nutrient Intake on Growth and Body Composition
The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.
- Conditions
- Infant Newborn
- Being tested
- Human Milk, Investigational infant formula, Milk based standard infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human MilkOther
ad lib
Investigational infant formulaOther
ad lib
Milk based standard infant formulaOther
ad lib
| Study group | Role | What they receive |
|---|---|---|
| Human Milk | Active comparator | ad lib Receives: Other: Human Milk |
| Milk based standard infant formula | Active comparator | ad lib Receives: Other: Milk based standard infant formula |
| Milk based investigational infant formula | Experimental | ad lib Receives: Other: Investigational infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 1- 365 days
Secondary outcomes (2)
Gastrointestinal tolerance
Measured: 1-365 days
Infant Anthropometrics
Measured: 1 - 365 days; 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startMar 2010
- Primary completionSep 2014
- Study completionAug 2016
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 Infant NewbornStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute of Child Health
- Responsible party
- Sponsor
- Investigators
- Barbara Marriage, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300000
- Sponsor's protocol ID
- AK65
- Status last verified
- Mar 2017
- First submitted
- 17 Feb 2011
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
PubMed 37929831
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Nutrient Intake on Growth and Body Composition
- ClinicalTrials.gov ID
- NCT01300000
- Acronym / sponsor ID
- AK65
- Conditions
- Infant Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Institute of Child Health
- Study start
- Mar 2010 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Feb 2011 (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.
The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Human Milk | Active comparator | Other: Human Milkad lib |
| Milk based standard infant formula | Active comparator | Other: Milk based standard infant formulaad lib |
| Milk based investigational infant formula | Experimental | Other: Investigational infant formulaad lib |
Who may qualify
- Ages
- 1 minute to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- good health
- singleton birth with gestational age 37-42 weeks
- infant's birth weight >or = to 2500 grams
- exclusive breastfeeding or exclusively formula feeding
- within a defined geographical boundary
Key exclusion criteria (4 listed)
- adverse maternal, fetal or infant medical history
- congenital disease or malformation affecting growth or development
- illness or social problems in mother or infant
- temporary residents
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 |
|---|---|---|
| Human Milkad lib | Other | Human Milk |
| Investigational infant formulaad lib | Other | Milk based investigational infant formula |
| Milk based standard infant formulaad lib | Other | Milk based standard infant formula |
Primary outcome
Weight gain
Time frame: 1- 365 days
2 secondary outcomes
Gastrointestinal tolerance
Time frame: 1-365 days
Infant Anthropometrics
Time frame: 1 - 365 days; 24 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 29 Mar 2017.
- Derived from this study: PubMed 37929831Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
- 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. This study is not recruiting at the moment.
Barbara Marriage, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Milk, Investigational infant formula and Milk based standard infant formula in people with Infant Newborn, run by Abbott Nutrition at 1 site in United Kingdom.
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 6 inclusion and 4 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 29 Mar 2017. 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 United Kingdom. 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?
Weight gain (time frame: 1- 365 days). 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 NCT01300000, 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 29 Mar 2017.