Efficacy and safety of preterm formula supplemented with energy substrates for the nutrition of infants of very low birth weight
| ISRCTN | ISRCTN61070850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61070850 |
| Secondary identifying numbers | 40/2006 |
- Submission date
- 12/05/2009
- Registration date
- 05/06/2009
- Last edited
- 03/03/2011
- 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
Dr Alejandro Gonzalez
Scientific
Scientific
Av. Coyoacan 1868 - 202
Col. Acacias
Mexico City
03240
Mexico
| Phone | +52 (0)155 5524 1792 |
|---|---|
| pegasso.100@hotmail.com |
Study information
| Study design | Phase III three-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy and safety of preterm formula addition with medium chain triglycerides or maltodextrins compared with milk formula without addition of energy substrates for nutrition of newborn very low birth weight: a randomised clinical trial |
| Study acronym | MCT oil, vlbw |
| Study objectives | 1. The preterm formula supplemented with medium chain triglyceride (MCT) oil to be administered to infants of very low birth weight is the most effective way to reach a weight of 1800 g in 16 days compared with patients fed the preterm formula supplemented with maltodextrin and the formula without added substrates 2. The preterm formula supplemented with MCT oil to be administered to infants of very low birth weight will be just as effective as the formula with maltodextrins and the formula without the addition of energy substrates to achieve a weight of 1800 g in 16 days based on clinical and biochemical parameters |
| Ethics approval(s) | Ethics Committee of the National Institute of Pediatrics approved on the 24th October 2006 (ref: 40/2006) |
| Health condition(s) or problem(s) studied | Very low birth weight |
| Intervention | Group 1 (n = 21): Preterm formula without supplements (control group) Group 2 (n = 21): Preterm formula supplemented with maltodextrin (10 kcal/day). The amount of maltodextrin in the formula will be 10 kcal/day at start and this will be gradually increased each day to 10 kcal. Group 3 (n = 21): Preterm formula supplemented with medium chain triglycerides. The amount of the medium chain triglycerides will be 10 kcal/day at start, and this will be increased each day to 10 kcal. Total duration of interventions: minimum 21 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Maltodextrin, medium chain triglycerides |
| Primary outcome measure | 1. Number of days required to reach 1800 g in weight 2. Type of treatment administered 3. Weight 4. Height 5. Cephalic perimeter 6. Mid-arm circumference Measured at 21 days. |
| Secondary outcome measures | 1. Biochemical parameters: serum albumin, prealbumin, total protein, creatinine, blood-urea nitrogen (BUN), nitrogen balance 2. Security settings: abdominal perimeter, vomiting, stool consistency, temperature, blood in stools, serum glucose, calcium, phosphorus, magnesium, triglycerides Measured at 21 days. |
| Overall study start date | 10/01/2007 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 63 |
| Key inclusion criteria | 1. Both male and female infants, aged less than 28 days 2. Hospitalised in the Intensive Care Unit (ICU) or Neonatal Intermediate Care Unit (NICU) 3. Weight less than 1500 g at birth 4. Fed exclusively via enteral route 5. Haemodynamic stability (arterio-venous 3 - 5) 6. Have not received prior formulas with added energy substrates 7. Signed informed consent by parents or guardians |
| Key exclusion criteria | 1. Patients suffering from inborn errors of metabolism in any variant or a disease in itself a negative influence on growth (congenital heart disease, kidney failure, genetic diseases) 2. Post-operative state greater than 72 hours |
| Date of first enrolment | 10/01/2007 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Av. Coyoacan 1868 - 202
Mexico City
03240
Mexico
03240
Mexico
Sponsor information
National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)
Government
Government
Insurgentes Sur 3700 - C
Col. Insurgentes Cuicuilco
Mexico City
03540
Mexico
| Phone | +52 (0)155 1084 0900 |
|---|---|
| pediatria_inp@prodigy.net.mx | |
| Website | http://www.salud.gob.mx/unidades/pediatria/ |
"ROR" |
https://ror.org/05adj5455 |
Funders
Funder type
Government
National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)
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 |
