Contact information
Type
Scientific
Primary contact
Dr Alejandro Gonzalez
ORCID ID
Contact details
Av. Coyoacan 1868 - 202
Col. Acacias
Mexico City
03240
Mexico
+52 (0)155 5524 1792
pegasso.100@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
40/2006
Study information
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
Acronym
MCT oil, vlbw
Study hypothesis
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
Ethics Committee of the National Institute of Pediatrics approved on the 24th October 2006 (ref: 40/2006)
Study design
Phase III three-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
Maltodextrin, medium chain triglycerides
Primary outcome measures
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 trial start date
10/01/2007
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
63
Participant 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
Recruitment start date
10/01/2007
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Mexico
Trial participating centre
Av. Coyoacan 1868 - 202
Mexico City
03240
Mexico
Sponsor information
Organisation
National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)
Sponsor details
Insurgentes Sur 3700 - C
Col. Insurgentes Cuicuilco
Mexico City
03540
Mexico
+52 (0)155 1084 0900
pediatria_inp@prodigy.net.mx
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)
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