Infant, Low Birth WeightPhase 2NCT00413985
Post Discharge Human Milk Fortifier in Preterm Infants
A Phase 2 study testing Nutrient-enriched human milk in people with Infant, Low Birth Weight, run by The Hospital for Sick Children at 9 sites in Canada.
Trial summary
The purpose of this study is to determine whether low birth weight (LBW) infants fed human milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks after hospital discharge will have better growth and neurodevelopment than infants fed HM alone. Read more about this study
- Who is it for?
- Ages 1 day to 4 months
- Conditions the study is for
- Infant, Low Birth Weight
- What is being tested?
- Nutrient-enriched human milk
- How many people
- 40 participants
- Where
- 9 sitesCanada
- Study dates
- Jan 2004to Nov 2007
- Phase
- Phase 2
- 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 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth Weight between 750-1800 g
- Gestational Age at birth between 26 and 32 weeks
- Singleton or twin birth (for twins to be eligible, both must meet eligibility criteria)
- Small for Gestational age or appropriate for gestational age
- ≥ 80% energy received from human milk in the previous three days
- ≥ 25% of human milk consumed orally in the previous three days
Show all 9Show fewer
- Mother agrees to exclusively feed her infant human nilk after discharge
- If so randomized, parents agree to supplement ~1/2 or the human milk provided to her infant as powdered human milk fortifier for 12 weeks after hospital discharge
- Subject's parents have voluntarily signed an informed consent form
Who cannot join
- Serious congenital or chromosomal anomalies that will affect growth
- Grade III or IV periventricular/intraventricular hemorrhage
- Received steroids within 14 days o randomization
- Asphyxia (hypoxia or ischemia) es evident by severe and permanent neurological data
- Maternal incapacity, including maternal cocaine or alcohol abuse dring pregnancy, or concurrent, or mother or infant has tested positive for HIV
- Principal residence of study family outside GTA
- Mother unable to verbally communicate in English
- A single feeding must be fortified > 24 kcal/oz or >50% of feeds need to be fortified
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
The Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Rouge Valley Centenary
Toronto, Ontario, M1E 4B9
The Scarborough Hospital
Toronto, Ontario, M1P 2V5
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Sunnybrook and Women's Health Sciences Centre
Toronto, Ontario, M5S 1B2
St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5
About this study
Official title: Growth and Development in Preterm Infants Fed Human Milk Containing a Powdered Human Milk Fortifier (HMF) Post Hospital Discharge
The purpose of this study is to determine whether low birth weight (LBW) infants fed human milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks after hospital discharge will have better growth and neurodevelopment than infants fed HM alone.
Read the detailed description
Consensus exists in the literature that a significant proportion of low birth weight (LBW, <1800 g) infants leave hospital with overt signs of under-nutrition (eg. growth retardation). Recent evidence from randomized control trials suggest that provision of nutrient-enriched feeding to formula-fed premature infants after hospital discharge improves their growth, accretion of lean body mass and bone mineral content compared to infants fed a standard term formula. While available data suggest an advantage of human milk feeding after hospital discharge, experimental evidence on which to base guidelines to enrich, or not to enrich, human milk (HM) are notably absent.
- Conditions
- Infant, Low Birth Weight
- Being tested
- Nutrient-enriched human milk
- Keywords
- Low Birth Weight, Fortified Human Milk, breastfeeding, infants, growth
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrient-enriched human milkDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth (weight, length and head circumference)
Body composition (fat-free mass, whole body mineral content, fat mass
Milk consumption
Estimated energy and nutrient intakes
Duration/exclusivity of breastfeeding
Morbidity (serious adverse events, hospital re-admissions)
Development (mental, motor, visual and language)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study startJan 2004
- Primary completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Low Birth WeightStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Deborah O'Connor, The Hospital for Sick Children
- Investigators
- Deborah L O'Connor, RD, PhD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413985
- Sponsor's protocol ID
- 1000003971
- Status last verified
- Dec 2013
- First submitted
- 19 Dec 2006
- Last updated
- 31 Dec 2013
- Results posted
- No
Publications
O'Connor DL, Khan S, Weishuhn K, Vaughan J, Jefferies A, Campbell DM, Asztalos E, Feldman M, Rovet J, Westall C, Whyte H; Postdischarge Feeding Study Group. Growth and nutrient intakes of human milk-fed preterm infants provided with extra energy and nutrients after hospital discharge. Pediatrics. 2008 Apr;121(4):766-76. doi: 10.1542/peds.2007-0054.
PubMed 18381542
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Development in Preterm Infants Fed Human Milk Containing a Powdered Human Milk Fortifier (HMF) Post Hospital Discharge
- ClinicalTrials.gov ID
- NCT00413985
- Acronym / sponsor ID
- 1000003971
- Conditions
- Infant, Low Birth Weight
- Keywords
- Low Birth Weight, Fortified Human Milk, breastfeeding, infants, growth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2004
- Primary completion
- Nov 2007 (actual)
- First posted
- 20 Dec 2006 (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 purpose of this study is to determine whether low birth weight (LBW) infants fed human milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks after hospital discharge will have better growth and neurodevelopment than infants fed HM alone.
Detailed description
Consensus exists in the literature that a significant proportion of low birth weight (LBW, <1800 g) infants leave hospital with overt signs of under-nutrition (eg. growth retardation). Recent evidence from randomized control trials suggest that provision of nutrient-enriched feeding to formula-fed premature infants after hospital discharge improves their growth, accretion of lean body mass and bone mineral content compared to infants fed a standard term formula. While available data suggest an advantage of human milk feeding after hospital discharge, experimental evidence on which to base guidelines to enrich, or not to enrich, human milk (HM) are notably absent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Birth Weight between 750-1800 g
- Gestational Age at birth between 26 and 32 weeks
- Singleton or twin birth (for twins to be eligible, both must meet eligibility criteria)
- Small for Gestational age or appropriate for gestational age
- ≥ 80% energy received from human milk in the previous three days
Key exclusion criteria (8 listed)
- Serious congenital or chromosomal anomalies that will affect growth
- Grade III or IV periventricular/intraventricular hemorrhage
- Received steroids within 14 days o randomization
- Asphyxia (hypoxia or ischemia) es evident by severe and permanent neurological data
- Maternal incapacity, including maternal cocaine or alcohol abuse dring pregnancy, or concurrent, or mother or infant has tested positive for HIV
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 |
|---|---|---|
| Nutrient-enriched human milk | Drug | – |
Primary outcome
Growth (weight, length and head circumference)
Body composition (fat-free mass, whole body mineral content, fat mass
Milk consumption
Estimated energy and nutrient intakes
Duration/exclusivity of breastfeeding
Morbidity (serious adverse events, hospital re-admissions)
Development (mental, motor, visual and language)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- Derived from this study: PubMed 18381542O'Connor DL, Khan S, Weishuhn K, Vaughan J, Jefferies A, Campbell DM, Asztalos E, Feldman M, Rovet J, Westall C, Whyte H; Postdischarge Feeding Study Group. Growth and nutrient intakes of human milk-fed preterm infants provided with extra energy and nutrients after hospital discharge. Pediatrics. 2008 Apr;121(4):766-76. doi: 10.1542/peds.2007-0054.
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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.
Deborah L O'Connor, RD, PhD principal investigator
The Hospital for Sick Children, Toronto Canada
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nutrient-enriched human milk in people with Infant, Low Birth Weight, run by The Hospital for Sick Children at 9 sites in Canada.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (weight, length and head circumference). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00413985, which also lists 1 linked publication.
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 31 Dec 2013.