Human Milk Fortifiers and Acid-Base Status | NCT00196482

Studies
Human Milk Fortifiers and Acid-Base Status

NCT00196482

Sponsor

University Medicine Greifswald

Status

Unknown status

Last Update Posted

Sep 12, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Premature Birth

Interventions

changing of fortifier

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 19, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2006

Last Update Posted Date

Sep 12, 2006Estimated

Name	Class
NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany	UNKNOWN

Description Module

Brief Summary

Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.

Two different compositions are tested, main difference is in electrolyte composiiton.

Detailed Description

Two groups each consisting of 15 infants with a birth weight below 2000g are studied.randomization is startified by three birth weigth classes (<1000g, 1000-1500g,1500 - 2000g) human milk fortifier is introduced in two steps after oral feeding is achieved. two acid-base status and electrolyte concentrations are measured. when metabolic acidosis, defined as BE < -6 mmol/l, occurs fortifier feeding is stopped, and after a wash-out period of three days the alternative product is used.again, occurence of metabolic acidosis, need for oral bicarbonate and effect on longitudinal growth an weight gain are registered.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
changing of fortifier	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
frequency of metabolic acidosis

Secondary Outcomes

Measure	Description	Time Frame
need for oral bicarbonate administartion
longitudinal growth
weight gain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

growing premature infants with a birth weight < 2000g

Exclusion Criteria:

congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Days

Maximum Age

3 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoph Fusch, Professor	Contact	+49-3834-86-	6420	fusch@uni-greifswald.de
Jens Rochow, MD	Contact	+49-3834-86-	6427	rochow@uni-greifswald.de

Overall Officials

Name	Affiliation	Role
Christoph Fusch	Department of Neonatology, University Hospital Greifswald	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital	Recruiting	Greifswald	M-V	17485	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33006765	Derived	Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications