Growth FailureNCT00548106
Safety Study of Infant Formula With Partially Hydrolized Whey
A study testing partially hydrolyzed whey and Nan HA in people with Growth Failure, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Growth Failure
- What is being tested?
- partially hydrolyzed whey and Nan HA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy term neonates whose mothers are not able or choose not to breastfeed for medical, social, or personal reasons, will be recruited
Who cannot join
- Twins
- Premature or low birth weight (< 2500 g).
- Chromosomal abnormalities or congenital malformations.
- Jaundice of more than 12 mg% and/or phototherapy.
- Treatment with antibiotics or other drugs during the last three days or more prior to the commencement of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a New Cow's Milk Infant Formula Containing Partially Hydrolized Whey
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving.
The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.
Read more
There will be two study groups, each receiving one of the following formulas:
- The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot.
- The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color
Read the detailed description
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving.
The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.
There will be two study groups, each receiving one of the following formulas:
- The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot.
- The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color
- Conditions
- Growth Failure
- Being tested
- partially hydrolyzed whey, Nan HA
- Keywords
- infant formula, milk allergy, hydrolized whey
- Medical subject headings
- Failure to Thrive, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partially hydrolyzed wheyDietary supplement
Also called Other names are not available yet.
Total infant feeding by study formula.
Nan HADietary supplement
Also called Not available yet.
Total infant diet by study formula.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Infants will be fed the new hydrolyzate formula. Receives: Dietary Supplement: partially hydrolyzed whey |
| 2 | Placebo comparator | Nan HA infant formula Receives: Dietary Supplement: partially hydrolyzed whey; Dietary Supplement: Nan HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth parameters, colic and bowel movements parameters.
Measured: 3 months
Secondary outcomes (1)
Side effects
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
Why it stopped: Study withdrawn due to the company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zvi Weizman, MD, Principal investigator, Head, Pediatric GI and Nutrition Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548106
- Sponsor's protocol ID
- Sor461707ctil
- Status last verified
- Jul 2010
- First submitted
- 22 Oct 2007
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Cow's Milk Infant Formula Containing Partially Hydrolized Whey
- ClinicalTrials.gov ID
- NCT00548106
- Acronym / sponsor ID
- Sor461707ctil
- Conditions
- Growth Failure
- Keywords
- infant formula, milk allergy, hydrolized whey
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to the company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- First posted
- 23 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving.
The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.
There will be two study groups, each receiving one of the following formulas:
- The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot.
- The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color
Detailed description
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving.
The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.
There will be two study groups, each receiving one of the following formulas:
- The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot.
- The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: partially hydrolyzed wheyInfants will be fed the new hydrolyzate formula. |
| 2 | Placebo comparator | Dietary Supplement: partially hydrolyzed whey, Dietary Supplement: Nan HANan HA infant formula |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy term neonates whose mothers are not able or choose not to breastfeed for medical, social, or personal reasons, will be recruited
Key exclusion criteria (5 listed)
- Twins
- Premature or low birth weight (< 2500 g).
- Chromosomal abnormalities or congenital malformations.
- Jaundice of more than 12 mg% and/or phototherapy.
- Treatment with antibiotics or other drugs during the last three days or more prior to the commencement of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| partially hydrolyzed wheyAlso: Other names are not available yet.Total infant feeding by study formula. | Dietary supplement | 1, 2 |
| Nan HAAlso: Not available yet.Total infant diet by study formula. | Dietary supplement | 2 |
Primary outcome
Growth parameters, colic and bowel movements parameters.
Time frame: 3 months
1 secondary outcome
Side effects
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zvi Weizman, MD principal investigator
Head, Pediatric GI and Nutrition Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partially hydrolyzed whey and Nan HA in people with Growth Failure, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth parameters, colic and bowel movements parameters. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.