Condition category
Pregnancy and Childbirth
Date applied
08/12/2008
Date assigned
23/12/2008
Last edited
23/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.hsjdbcn.org/index.jsp

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

Publication citations

Additional files

Editorial Notes