Contact information
Type
Scientific
Primary contact
Prof Lourdes Ibanez
ORCID ID
Contact details
Endocrinology Unit
Hospital Sant Joan de Deu
ESplugues
08950
Spain
+34 93 28 04 000
libanez@hsjdbcn.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Influence of early feeding in subsequent cardiovascular risks in infants born small for gestational age: a randomised controlled trial
Acronym
PSO
Study hypothesis
1. Breastfed small for gestational age (SGA) babies will gain more lean mass and less fat mass over the first 4 months of life
2. SGA babies will have more vsiceral fat at age 24 months as compared to babies born appropriate for gestational age (AGA)
3. SGA babies fed enriched formula will be more insulin resistant, have higher levels of insulin-like growth factor 1 (IGF-1) and altered levels of adipokines, as compared to breastfed SGA babies and SGA babies fed with regular formula
Ethics approval
Committee of Hospital Sant Joan de Déu, Esplugues have given approval on the 15th May 2008
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Small for gestational age (SGA), adipokines, cardiovascular risk factors
Intervention
Newborns born SGA who will not be breastfed will be randomised to receive a regular or an enriched formula for 4 months. Assessments at birth, 15 days, 4, 12 and 24 months (sampling, dual energy X-ray absorptiometry [DXA] and ultrasound).
Regular formula: Fat: 28.9 g%; carhohydrates: 55.0 g%; proteins: 11.7 g%
Enriched formula: Fat: 24.7 g%; carbohydrates: 54.9 g%; proteins: 14.5 g%
Feeding is ad libitum and following the recommendations of the primary care paediatricians. This is usually every 3 hours the first month, and every 4 hours thereafter. No additional food is allowed until after month 4.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Body composition at age 15 days and at age 4, 12 and 24 months (DXA).
Secondary outcome measures
1. Insulin
2. IGF-1
3. Adipokines
4. Visceral fat
Measured in cord blood, and in fasting samples at age 4, 12 and 24 months.
Overall trial start date
10/06/2008
Overall trial end date
10/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Maternally uncomplicated pregnancy (no gestational diabetes, no pre-eclampsia, no use of alcohol, drugs or illicit substances), with delivery at Hospital Sant Joan de Déu in Barcelona
2. Birthweight AGA (between -1 and +1 SD) or SGA (between 1.8 kg and -2 SD) after a term gestation (37 - 42 weeks)
3. Availability of cord serum
4. Ethnically Catalan background
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
90 (SGA), 50 (AGA)
Participant exclusion criteria
1. Dysmorphic features
2. 10-minute Apgar score below 7
Recruitment start date
10/06/2008
Recruitment end date
10/08/2010
Locations
Countries of recruitment
Spain
Trial participating centre
Endocrinology Unit
ESplugues
08950
Spain
Sponsor information
Organisation
Hospital Sant Joan de Deu (Spain)
Sponsor details
Passeig de Sant Joan de Deu 2
Esplugues
08950
Spain
+34 93 28 04 000
libanez@hsjdbcn.org
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: PI080443)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary