Birth WeightNCT00134771
Trial of Nutritional Supplementation in Infants Born Small for Gestational Age
A study testing Nutrient enriched infant formula in people with Birth Weight, run by Institute of Child Health at 6 sites in United Kingdom.
Trial summary
The purpose of this study was to determine whether giving a nutrient enriched formula to infants born small-for-gestational age benefits blood pressure, growth and body composition by six months of age. Read more about this study
- Who is it for?
- Ages 0 years to 10 days
- Conditions the study is for
- Birth Weight
- What is being tested?
- Nutrient enriched infant formula
- How many people
- Not given
- Where
- 6 sitesUnited Kingdom
- Study dates
- Feb 2001to Jun 2003
- 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 0 years to 10 days
- All sexes
- Child
Who may be able to join
- Infants who are formula fed from birth
- Infants whose birthweights are less than 20th centile
- Singleton births
- Gestation > 37 weeks
- Infants free from major congenital disease
Who cannot join
- Infants who are breast-fed
- Multiple births
- Birthweight > 20th centile
- Infants with congenital disease
- Gestation < 37 weeks
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
The Queen Mother's Hospital, Yorkhill
Glasgow, G3 8SJ
Maternity Hospital, Glasgow Royal Infirmary
Glasgow, G4 ONA
Maternity Unit, Southern General Hospital, 1345 Govan Road
Glasgow, G51 4TF
MRC Childhood Nutrition Research Centre, Inst of Child Health
London, WC1N 1EH
Maternity Unit, Royal Alexandra Hospital, Corsebar Road
Paisley, PA2 9PN
Neonatal Unit, Wishaw Hospital, 50 Netherton St
Wishaw, Lanrkshire, ML2 ODP
About this study
The purpose of this study was to determine whether giving a nutrient enriched formula to infants born small-for-gestational age benefits blood pressure, growth and body composition by six months of age.
Read the detailed description
Infants born small for gestational age often show impaired growth during childhood and reduced height as adults. Infants who are breast-fed from birth show greater 'catch-up' growth during the first few months of life than those who are formula fed but it is not clear what factors in breast milk (ie protein, nucleotides, LCPUFAs) are responsible for this 'catch-up' growth. This RCT compares the effects of using an enriched formula with increased protein and modified triglyceride (palmitate predominantly in Sn-2 position) against a standard infant formula from birth to six months on infants whose birth weights are below the 20th centiles for gestational age.
Infants are measured by a research midwife within 10 days of birth (at randomisation), 8, 16 and 26 weeks of age. At randomisation consent from the mother is taken and information collected about the pregnancy, social, demographic and medical data. At this and each further visit anthropometric measurements including skinfolds will be collected in addition to blood pressure and bio-electrical impedence at six months. A sub-sample of infants will have their body composition assessed by deuterium labelled water at six months. Data on health, weaning diets and bowel function are also collected at each visit.
- Conditions
- Birth Weight
- Being tested
- Nutrient enriched infant formula
- Keywords
- Infants whose birthweight is less than the 20th centile for gestational age (UK standards), Infants who are formula fed from birth, Singletons, Infants free from major congenital disease
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrient enriched infant formulaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight, length, head circumference at 6 months
Secondary outcomes (2)
Body composition at 6 months
Blood pressure at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startFeb 2001
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth WeightStudies 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Atul Singhal, Principal investigator, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134771
- Sponsor's protocol ID
- 99/2/109
- Status last verified
- Aug 2005
- First submitted
- 24 Aug 2005
- Last updated
- 7 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Nutritional Supplementation in Infants Born Small for Gestational Age
- ClinicalTrials.gov ID
- NCT00134771
- Acronym / sponsor ID
- 99/2/109
- Conditions
- Birth Weight
- Keywords
- Infants whose birthweight is less than the 20th centile for gestational age (UK standards), Infants who are formula fed from birth, Singletons, Infants free from major congenital disease
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Feb 2001
- Study completion
- Jun 2003
- First posted
- 25 Aug 2005 (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 purpose of this study was to determine whether giving a nutrient enriched formula to infants born small-for-gestational age benefits blood pressure, growth and body composition by six months of age.
Detailed description
Infants born small for gestational age often show impaired growth during childhood and reduced height as adults. Infants who are breast-fed from birth show greater 'catch-up' growth during the first few months of life than those who are formula fed but it is not clear what factors in breast milk (ie protein, nucleotides, LCPUFAs) are responsible for this 'catch-up' growth. This RCT compares the effects of using an enriched formula with increased protein and modified triglyceride (palmitate predominantly in Sn-2 position) against a standard infant formula from birth to six months on infants whose birth weights are below the 20th centiles for gestational age.
Infants are measured by a research midwife within 10 days of birth (at randomisation), 8, 16 and 26 weeks of age. At randomisation consent from the mother is taken and information collected about the pregnancy, social, demographic and medical data. At this and each further visit anthropometric measurements including skinfolds will be collected in addition to blood pressure and bio-electrical impedence at six months. A sub-sample of infants will have their body composition assessed by deuterium labelled water at six months. Data on health, weaning diets and bowel function are also collected at each visit.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 0 years to 10 days
- Sex
- All
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants who are formula fed from birth
- Infants whose birthweights are less than 20th centile
- Singleton births
- Gestation > 37 weeks
- Infants free from major congenital disease
Key exclusion criteria (5 listed)
- Infants who are breast-fed
- Multiple births
- Birthweight > 20th centile
- Infants with congenital disease
- Gestation < 37 weeks
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 |
|---|---|---|
| Nutrient enriched infant formula | Drug | – |
Primary outcome
Weight, length, head circumference at 6 months
2 secondary outcomes
Body composition at 6 months
Blood pressure at six 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 7 Nov 2005.
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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.
Atul Singhal principal investigator
Institute of Child Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrient enriched infant formula in people with Birth Weight, run by Institute of Child Health at 6 sites 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 5 inclusion and 5 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 7 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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, length, head circumference at 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2005.