Infant, Premature, DiseasesNCT02216292
Impact of Preterm Single Donor Milk in Very Low Birth Weight Infants
An observational study of Infant, Premature, Diseases, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Human milk is the best source of enteral nutrition for the preterm infant. However during the infants first hours and days of life breastmilk from the own mother is usually not available. Read more about this study
- Who is it for?
- Ages 1 minute to 1 year
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- Preterm Single Donor Milk Group
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2012to Jun 2014
- Phase
- Observational
- 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 minute to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: inborn very low birth weight infants with a birthweight <1500g and a gestational age <32 weeks
Who may be able to join
- very low birth weight infants with a birthweight <1500g
- Gestational Age <32 weeks
- Informed consent
Who cannot join
- major congenital malformations
- systemic metabolic diseases
- short bowl syndrome
- gastrointestinal abnormalities
- when preterm infant was transferred or discharged
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Preterm Single Donor Milk on Enteral Feeding in Very Low Birth Weight Infants
Human milk is the best source of enteral nutrition for the preterm infant. However during the infants first hours and days of life breastmilk from the own mother is usually not available. Until May 2012 the practice in the Neonatal Division of the Department of Pediatrics /Medical University Vienna was to start with formula feedings within the first 6 hours of life of a premature infant and switch over to breastmilk as soon it was available. In June 2012 the investigators changed this feeding regimen and started to use single donor milk of mothers of preterm infants for the first hours and days of the preterm infants life. In a prospective observational study the investigators evaluated the impact of single donor milk from preterm infants on time to full enteral feedings, gastrointestinal tolerance and NEC incidence in preterm infants with a birthweight below 1500 grams and a gestational below 32 weeks. Data will be compared with a historical control group starting with preterm formula as source of enteral nutrition. The investigators hypothesize that starting enteral nutrition with single donor milk of mothers from preterm infants with shorten time to full enteral feedings.
- Conditions
- Infant, Premature, Diseases
- Being tested
- Control Group, Preterm Single Donor Milk Group
- Keywords
- preterm single donor milk, human milk, very lo birth weight infants, enteral feedings, NEC
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Infants received preterm formula during their first days of life until breastmilk from their own mother was available
Preterm Single Donor Milk GroupOther
Infants received preterm single donor milk during their first days of life until breastmilk from their own mother was available
| Study group | Role | What they receive |
|---|---|---|
| Preterm Single Donor Milk Group | The prospective study group = preterm single donor milk group (PSDM-Group) from June 2012 - April 2013 Receives: Other: Preterm Single Donor Milk Group | |
| Control Group | Retrospective control group receiving no donor milk = control group from March 2011 - May 2012 Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to full enteral feeding
Full enteral feedings are defined as an enteral inane of 135-145ml/kg/d
Measured: birth up to 40 weeks of gestation
Secondary outcomes (4)
necrotizing enterocolitis
Necrotising enterocolitis (NEC) was defined according to the stages by Bell as proven NEC grade 2a.
Measured: birth to 40 weeks of gestation
Gastric residuals
Gastric residuals are a parameter for gastrointestinal tolerance and are determined every three hours before the next meal is given and are aspirated via a gastric tube Gastric residuals are measured in ml/kg per meal. Furthermore the color is documented (milky, clear, mucous, bile stained, bloody)
Measured: birth to 7th day of life
Frequency of stool
Number of stools per day
Measured: birth until 14th day of life
culture positive sepsis
Measured: birth to 40th week of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadja Haiden,MD, Medical University of Vienna
- Investigators
- Nadja Haiden, Prof.MD, Principal investigator, Medical University of Vienna, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216292
- Sponsor's protocol ID
- PSDM001
- Status last verified
- Aug 2014
- First submitted
- 11 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preterm Single Donor Milk on Enteral Feeding in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT02216292
- Acronym / sponsor ID
- PSDM001
- Conditions
- Infant, Premature, Diseases
- Keywords
- preterm single donor milk, human milk, very lo birth weight infants, enteral feedings, NEC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Aug 2014 (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.
Human milk is the best source of enteral nutrition for the preterm infant. However during the infants first hours and days of life breastmilk from the own mother is usually not available. Until May 2012 the practice in the Neonatal Division of the Department of Pediatrics /Medical University Vienna was to start with formula feedings within the first 6 hours of life of a premature infant and switch over to breastmilk as soon it was available. In June 2012 the investigators changed this feeding regimen and started to use single donor milk of mothers of preterm infants for the first hours and days of the preterm infants life. In a prospective observational study the investigators evaluated the impact of single donor milk from preterm infants on time to full enteral feedings, gastrointestinal tolerance and NEC incidence in preterm infants with a birthweight below 1500 grams and a gestational below 32 weeks. Data will be compared with a historical control group starting with preterm formula as source of enteral nutrition. The investigators hypothesize that starting enteral nutrition with single donor milk of mothers from preterm infants with shorten time to full enteral feedings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm Single Donor Milk Group | – | Other: Preterm Single Donor Milk GroupThe prospective study group = preterm single donor milk group (PSDM-Group) from June 2012 - April 2013 |
| Control Group | – | Other: Control GroupRetrospective control group receiving no donor milk = control group from March 2011 - May 2012 |
Who may qualify
- Ages
- 1 minute to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- inborn very low birth weight infants with a birthweight <1500g and a gestational age <32 weeks
Key inclusion criteria (3 listed)
- very low birth weight infants with a birthweight <1500g
- Gestational Age <32 weeks
- Informed consent
Key exclusion criteria (5 listed)
- major congenital malformations
- systemic metabolic diseases
- short bowl syndrome
- gastrointestinal abnormalities
- when preterm infant was transferred or discharged
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 |
|---|---|---|
| Control GroupInfants received preterm formula during their first days of life until breastmilk from their own mother was available | Other | Control Group |
| Preterm Single Donor Milk GroupInfants received preterm single donor milk during their first days of life until breastmilk from their own mother was available | Other | Preterm Single Donor Milk Group |
Primary outcome
Time to full enteral feeding
Time frame: birth up to 40 weeks of gestation
Full enteral feedings are defined as an enteral inane of 135-145ml/kg/d
4 secondary outcomes
necrotizing enterocolitis
Time frame: birth to 40 weeks of gestation
Gastric residuals
Time frame: birth to 7th day of life
Frequency of stool
Time frame: birth until 14th day of life
culture positive sepsis
Time frame: birth to 40th week of gestation
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 13 Aug 2014.
Related trials for Infant, Premature, Diseases
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Nadja Haiden, Prof.MD principal investigator
Medical University of Vienna, Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, Diseases, run by Medical University of Vienna at 1 site in Austria.
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 3 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: finished, as of the sponsor's last update on 13 Aug 2014. 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 Austria. 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.
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?
Time to full enteral feeding (time frame: birth up to 40 weeks of gestation). 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 13 Aug 2014.