Effects of feeding during the first months of life in post-natal health in babies born small for gestational age (SGA)
| ISRCTN | ISRCTN36204907 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36204907 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/12/2008
- Registration date
- 23/12/2008
- Last edited
- 23/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Lourdes Ibanez
Scientific
Scientific
Endocrinology Unit
Hospital Sant Joan de Deu
ESplugues
08950
Spain
| Phone | +34 93 28 04 000 |
|---|---|
| libanez@hsjdbcn.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Influence of early feeding in subsequent cardiovascular risks in infants born small for gestational age: a randomised controlled trial |
| Study acronym | PSO |
| Study objectives | 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(s) | Committee of Hospital Sant Joan de Déu, Esplugues have given approval on the 15th May 2008 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 10/06/2008 |
| Completion date | 10/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 90 (SGA), 50 (AGA) |
| Key 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 |
| Key exclusion criteria | 1. Dysmorphic features 2. 10-minute Apgar score below 7 |
| Date of first enrolment | 10/06/2008 |
| Date of final enrolment | 10/08/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Endocrinology Unit
ESplugues
08950
Spain
08950
Spain
Sponsor information
Hospital Sant Joan de Deu (Spain)
Hospital/treatment centre
Hospital/treatment centre
Passeig de Sant Joan de Deu 2
Esplugues
08950
Spain
| Phone | +34 93 28 04 000 |
|---|---|
| libanez@hsjdbcn.org | |
| Website | http://www.hsjdbcn.org/index.jsp |
"ROR" |
https://ror.org/001jx2139 |
Funders
Funder type
Research organisation
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: PI080443)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
