The results of nutritional support with energy and nutrient dense formula for children with congenital heart
defects
Design
clinical trial; single arm; without control group; without blinding; non randomized; phase 2; 40 patients
Settings and conduct
Infants on regular infant formula will be switched completely to high energy-high protein formula. Infants on breast milk and infant milk formula (IMF) will be given high energy-high protein formula to replace the IMF; and undernourished Infants on breast milk only will be included (for top up by high energy-high protein formula) at the discretion of the clinician.The infants will be evaluated for growth parameters (weight, length, MUAC and head circumference) at recruitment, every 3 weeks until surgery, or until they have reached a WFA of ≥-1SD
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Infants diagnosed with medium/high risk congenital heart diseases
- Undernutrition infants with WFA ≤-2SD
- Infants who are candidates for surgery (palliative surgery or total correction)
- Infants aged under 9 months
- Infants with gestational age ≥37 weeks
Exclusion criteria:
- Infants with other medical problems affecting nutrition
- Infants with cow’s milk allergy or galactosaemia
- Infants with low risk lesions
- Intants who receive parenteral nutrition
Intervention groups
Single arm study; Intervention group 1: high energy-high protein formula
Main outcome variables
weight, height, weight for age Z score (WFA), weight for length z score (WFL), length for age z score (LFZ), Mid arm circumference (MUAC), head circumference (HC)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191224045880N1
Registration date:2020-02-18, 1398/11/29
Registration timing:retrospective
Last update:2020-02-18, 1398/11/29
Update count:0
Registration date
2020-02-18, 1398/11/29
Registrant information
Name
Ehsan Aghaei Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 9662
Email address
ehsanaghaei1358@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2018-12-22, 1397/10/01
Trial completion date
2019-05-22, 1398/03/01
Scientific title
Nutritional support with energy and nutrient-dense formula for children with congenital heart defects: A clinical trial
Public title
Nutritional support with energy and nutrient-dense formula for children with congenital heart defects: A clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children with moderate/high risk cardiac defects who are candidates for surgical repair
being undernourished (Weight For Age z-score ≤ - 2)
Exclusion criteria:
Infants known to have non-cardiac medical problems that could independently affect nutrient intake, such as gastrointestinal malformations, renal failure, liver disease, neurological sequelae
genetic conditions associated with growth failure
Infants with low risk cardiac defects
presence of cow’s milk allergy and galactosaemia
history of operation within 4 weeks from the time of screening
receiving parenteral nutrition
Age
To 9 months old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Children's Medical Center, 62 Qarib St. , Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3543
Health conditions studied
1
Description of health condition studied
congenital heart diseases
ICD-10 code
Q24.9
ICD-10 code description
Congenital malformation of heart, unspecified
2
Description of health condition studied
malnutrition
ICD-10 code
E64
ICD-10 code description
Sequelae of malnutrition and other nutritional deficiencies
Primary outcomes
1
Description
weight for age Z score
Timepoint
3,6,9,12 weeks after the administration of the high-energy- high protein formula
Method of measurement
scale
Secondary outcomes
1
Description
weight for length Z score
Timepoint
3,6,9,12 weeks after the administration of the high energy-high protein formula
Method of measurement
scale and meter
2
Description
length for age Z score
Timepoint
3,6,9,12 weeks after the administration of the high energy-high protein formula
Method of measurement
meter
3
Description
head circumference
Timepoint
3,12 weeks after the administration of the high energy-high protein formula
Method of measurement
meter
4
Description
Mid-upper arm circumference
Timepoint
3,12 weeks after the administration of the high energy-high protein formula
Method of measurement
meter
Intervention groups
1
Description
Intervention group: In this study, infants on regular infant formula will be switched completely to energy- and nutrient-dense formula (100 kcal and 2.6 g protein per 100 ml; Infatrini®, Nutricia, Zoetermeer, the Netherlands). Infants who receive a combination of breast milk and regular infant formula will continue breast milk in addition to energy- and nutrient-dense formula to replace the regular formula. Infants who receive only breast milk will receive, at the discretion of the clinician, energy- and nutrient-dense formula. The dose of the administered energy- and nutrient-dense formula will initiate with 35 kcal/kg/day to reach 100 Kcal/kg/day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's medical center
Full name of responsible person
Ehsan Aghaei Moghadam
Street address
Children's Medical Center, 62 Qarib St. , Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 9662
Email
ehsanaghaei1358@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
gsia@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Danone Nutricia
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
NL
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Aghaei Moghadam
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Children's Medical Center, 62 Qarib St. , Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 9662
Email
ehsanaghaei1358@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Aghaei Moghadam
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Children's Medical Center, 62 Qarib St. , Keshavarz Blvd., Tehran 14194, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 9662
Fax
Email
ehsanaghaei1358@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Aghaei Moghadam
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Children's Medical Center, 62 Qarib St. , Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 9662
Email
ehsanaghaei1358@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available