Post Discharge Human Milk Fortifier in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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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

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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

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Infant, Low Birth Weight

Keywords

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Low Birth Weight Fortified Human Milk breastfeeding infants growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Nutrient-enriched human milk

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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

Minimum Eligible Age

1 Day

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Deborah O'Connor

Associate Chief, Clinical Dietetics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah L O'Connor, RD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

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Canada

References

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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.

Reference Type DERIVED

PMID: 18381542 (View on PubMed)

Other Identifiers

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1000003971

Identifier Type: -

Identifier Source: org_study_id

Post Discharge Human Milk Fortifier in Preterm Infants

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Nutrient-enriched human milk

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Canadian Institutes of Health Research (CIHR)

The Hospital for Sick Children

Responsible Party

Deborah O'Connor

Principal Investigators

Deborah L O'Connor, RD, PhD

Locations

The Credit Valley Hospital

Rouge Valley Centenary

The Scarborough Hospital

Toronto East General Hospital

St. Michael's Hospital

Mount Sinai Hospital

The Hospital for Sick Children

Sunnybrook and Women's Health Sciences Centre

St. Joseph's Health Centre

Countries

References

Other Identifiers

1000003971