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Trial registered on ANZCTR


Registration number
ACTRN12613000481774
Ethics application status
Approved
Date submitted
3/04/2013
Date registered
30/04/2013
Date last updated
30/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Improvement of feeding tolerance by using a new formula in preterm neonates
Scientific title
Effects of a new hydrolyzed powdered formula on feeding tolerance in preterm neonates: a randomized placebo-controlled study
Secondary ID [1] 282146 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
HPFN (Hydrolyzed Powdered Formula in Neonates)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Feeding tollerance in very low birth weight neonates
 288648 0
Condition category
Condition code
Diet and Nutrition 288989 288989 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 289107 289107 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neonates in group 1 receive a new powdered hydrolyzed formula. Formula will be oral liquid administered, divided in 8 feed/day, by enteral route, for the first 4 weeks of life. Daily volume will be adjusted on body weight (150 ml/Kg/day).

Macronutrients formula composition is reported below per 100 ml of product:
whey protein 3.1 (g), lactose 4.6 (g), maltodextrins 4.2 (g), medium chain triglicerides 0.6 (g), linoleic acid 710 (mg), linolenic acid 80 (mg), arachidonic acid 18 (mg), docosahexaenoic acid 18 (mg).
Intervention code [1] 286753 0
Treatment: Other
Comparator / control treatment
Neonates in group 2 receive a standard formula. Formula will be oral liquid administered, divided in 8 feed/day, by enteral route, for the first 4 weeks of life. Daily volume will be adjusted on body weight (150 ml/Kg/day).


Composition of this formula is reported below per 100 ml of product:
whey protein 3.1 (g), lactose 5 (g), maltodextrins 2.8 (g), medium chain triglicerides 0.6 (g), linoleic acid 603 (mg), linolenic acid 85 (mg), arachidonic acid 17.5 (mg), docosahexaenoic acid 17.5 (mg).
Control group
Active

Outcomes
Primary outcome [1] 289103 0
Time to reach full enteral feeding (120 Kcal/Kg/day)
Timepoint [1] 289103 0
1 week of life (rate of neonates reaching full enteral feeding within 7 day of life)
Secondary outcome [1] 301820 0
Duration of hospital stay
Timepoint [1] 301820 0
40 weeks of postconceptional age (rate of neonates discharged within 40 weeks of postconceptional age)

Eligibility
Key inclusion criteria
Newborns with birth weight <1500 g consecutively observed in Neonatal Intensive Care Unit
Minimum age
0 Days
Maximum age
20 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Congenital or maternal infections, immunodeficiency, malformations, syndrome, genetic defects, evidence of infections and NEC before enrolment, critically ill condition (blood pH < 6.8, or hypoxia with persistent bradycardia for at least 1 hour), and hospitalization less than 2 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All neonates observed in NICU with a body birth weight < 1500 g will be considered eligible for the study. Enrolled subject will be randomly allocated to group 1 (hydrolyzed powdered formula) or group 2 (standard formula for preterm). The two powdered formula will be provided in identical boxes without indication of group identity or content. Each box will be labeled with a unique serial number according to the randomization list, which was not available to the investigators until the data had been obtained,entered in the database and analyzed by a blinded statistician. After randomization, nurses, blinded to the study aims, gave the assigned preparation as liquid formula after specific dilution
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization list
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Kolmogorov-Smirnov test will be used to determine if variables are normally distributed. For continuous variables, groups will be compared using the test of equality of means, the Mann-Whitney test and Kruskal-Wallis test. The chi-square test and Fisher’s exact test will be used for categorical variables. For two related dichotomous variables, the McNemar test will be used to detect differences between study groups. We will perform a multivariate analysis (binary logistic regression) to evaluate whether PDA closure would be influenced by GA, modality of delivery, multiple birth, BW, sex, Apgar score at 5 minutes, or by study group assignment. The level of significance for all statistical tests is 2-sided, p<0.05. Statistical analysis will be performed, per intention-to-treat, by a statistician blinded to patient group assignment with SPSS Version 18.0 for Windows (SPSS Inc., Chicago, IL).
To demonstrate a reduction in the time to reach full enteral feeding of 5 d (15 +/- 5 d vs. 10 +/- d) in subjects receiving hydrolyzed formula with 97% power and type 1 error = 0.05 (2-tailed test), a minimum sample size of 30 patients for each group was required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4944 0
Italy
State/province [1] 4944 0
Rome

Funding & Sponsors
Funding source category [1] 286913 0
University
Name [1] 286913 0
University of rome "La Sapienza"
Country [1] 286913 0
Italy
Primary sponsor type
University
Name
University of Rome "La Sapienza"
Address
Piazzale Aldo Moro, 5 00185 Roma
06 49911
Country
Italy
Secondary sponsor category [1] 285700 0
University
Name [1] 285700 0
Department of Translational Medicine, University Federico II of Naples
Address [1] 285700 0
via Pansini 5, 80131, Naples, Italy
Country [1] 285700 0
Italy

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38578 0
Prof Gianluca Terrin
Address 38578 0
Dipartimento Scienze Ginecologiche-Ostetriche e Scienze Urologiche Universita di Roma La Sapienza viale Regina Elena 285 00198, Rome, Italy

Country 38578 0
Italy
Phone 38578 0
+39 3339191207
Fax 38578 0
Email 38578 0
gianluca.terrin@uniroma1.it
Contact person for public queries
Name 38579 0
Gianluca Terrin
Address 38579 0
Dipartimento Scienze Ginecologiche-Ostetriche e Scienze Urologiche Universita di Roma La Sapienza viale Regina Elena 285 00198, Rome, Italy
Country 38579 0
Italy
Phone 38579 0
+39 3339191207
Fax 38579 0
Email 38579 0
gianluca.terrin@uniroma1.it
Contact person for scientific queries
Name 38580 0
Gianluca Terrin
Address 38580 0
Dipartimento Scienze Ginecologiche-Ostetriche e Scienze Urologiche Universita di Roma La Sapienza viale Regina Elena 285 00198, Rome, Italy
Country 38580 0
Italy
Phone 38580 0
+39 3339191207
Fax 38580 0
Email 38580 0
gianluca.terrin@uniroma1.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.