Premature Birth of NewbornPhase 4NCT01759134
Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas
A Phase 4 study testing Post discharge formula in people with Premature Birth of Newborn, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas. Read more about this study
- Who is it for?
- Ages 30 to 34 weeks
- Conditions the study is for
- Premature Birth of Newborn
- What is being tested?
- Post discharge formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jun 2014
- Phase
- Phase 4
- 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 30 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).
- Gestational week 30-34.
Who cannot join
- Congenital major malformation (e.g. congenital heart disease).
- Chromosomal abnormality (e.g. Down's syndrome)
- Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC
- Milk allergy
- Chronic disease (e.g. oxygen treatment)
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.
Read the detailed description
Infants will be randomized upon discharge from the NICU. We will follow weight, height and head circumference for three months following discharge, In addition any feeding difficulties will be noted.
- Conditions
- Premature Birth of Newborn
- Being tested
- Post discharge formula
- Keywords
- Premature neonate, Post-discharge, Formula
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post discharge formulaOther
Babies will be given either materna sensitive or similac neosure
| Study group | Role | What they receive |
|---|---|---|
| Post Discharge Formula | Experimental | Babies will be given formula for first three months post discharge Receives: Other: Post discharge formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
growth
weight (kg), length (cm), head circumference (cm).
Measured: 3 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Birth of NewbornStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alona Bin-Nun, MD, Principal investigator, Shaare Zedek Medical CenterCathy Hammerman, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759134
- Sponsor's protocol ID
- chammermanpdc
- Status last verified
- Dec 2012
- First submitted
- 2 Jan 2012
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas
- ClinicalTrials.gov ID
- NCT01759134
- Acronym / sponsor ID
- chammermanpdc
- Conditions
- Premature Birth of Newborn
- Keywords
- Premature neonate, Post-discharge, Formula
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 2 Jan 2013 (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 objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.
Detailed description
Infants will be randomized upon discharge from the NICU. We will follow weight, height and head circumference for three months following discharge, In addition any feeding difficulties will be noted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post Discharge Formula | Experimental | Other: Post discharge formulaBabies will be given formula for first three months post discharge |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).
- Gestational week 30-34.
Key exclusion criteria (5 listed)
- Congenital major malformation (e.g. congenital heart disease).
- Chromosomal abnormality (e.g. Down's syndrome)
- Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC
- Milk allergy
- Chronic disease (e.g. oxygen treatment)
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 |
|---|---|---|
| Post discharge formulaBabies will be given either materna sensitive or similac neosure | Other | Post Discharge Formula |
Primary outcome
growth
Time frame: 3 months post discharge
weight (kg), length (cm), head circumference (cm).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
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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.
Alona Bin-Nun, MD principal investigator
Shaare Zedek Medical Center
Cathy Hammerman, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Post discharge formula in people with Premature Birth of Newborn, run by Shaare Zedek 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 2 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: stopped early, as of the sponsor's last update on 25 Oct 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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 (time frame: 3 months post discharge). 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 25 Oct 2013.