Condition category
Pregnancy and Childbirth
Date applied
12/05/2009
Date assigned
05/06/2009
Last edited
03/03/2011
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

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

http://www.salud.gob.mx/unidades/pediatria/

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

Publication citations

Additional files

Editorial Notes