NCT00134771

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2001

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
Last Updated

November 7, 2005

Status Verified

August 1, 2005

First QC Date

August 24, 2005

Last Update Submit

November 4, 2005

Conditions

Birth Weight

Keywords

Infants whose birthweight is less than the 20th centile for gestational age (UK standards)Infants who are formula fed from birthSingletonsInfants free from major congenital disease

Outcome Measures

Primary Outcomes (1)

  • Weight, length, head circumference at 6 months

Secondary Outcomes (2)

  • Body composition at 6 months

  • Blood pressure at six months

Interventions

Nutrient enriched infant formulaDRUG

Eligibility Criteria

Age0 Years - 10 Days
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Infants who are breast-fed
  • Multiple births
  • Birthweight \> 20th centile
  • Infants with congenital disease
  • Gestation \< 37 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Neonatal Unit, Wishaw Hospital, 50 Netherton St

Wishaw, Lanrkshire, ML2 ODP, United Kingdom

Location

The Queen Mother's Hospital, Yorkhill

Glasgow, G3 8SJ, United Kingdom

Location

Maternity Hospital, Glasgow Royal Infirmary

Glasgow, G4 ONA, United Kingdom

Location

Maternity Unit, Southern General Hospital, 1345 Govan Road

Glasgow, G51 4TF, United Kingdom

Location

MRC Childhood Nutrition Research Centre, Inst of Child Health

London, WC1N 1EH, United Kingdom

Location

Maternity Unit, Royal Alexandra Hospital, Corsebar Road

Paisley, PA2 9PN, United Kingdom

Location

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Atul Singhal

    Institute of Child Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 25, 2005

Study Start

February 1, 2001

Study Completion

June 1, 2003

Last Updated

November 7, 2005

Record last verified: 2005-08

Locations

GB(6)