Premature InfantsNutriprotoNCT03217045
Nutrition Protocol and Premature Infants' Growth
An observational study of Premature Infants and Nutrition Deficiency Due to Insufficient Food, run by Central Hospital, Nancy, France.
Trial summary
Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the first weeks of life is responsible for postnatal growth restriction and adverse long-term outcomes. Read more about this study
- Who is it for?
- Ages 1 day to 77 days
- Conditions the study is for
- Premature Infants, Nutrition Deficiency Due to Insufficient Food, Growth Retardation
- What is being tested?
- nutrition protocol introduction
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 1 Apr 2017
- 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 day to 77 days
- All sexes
- No healthy volunteers
- Child
Study population: All infants born between 26 to 32 weeks gestation and admitted to our level III NICU were eligible and included in the study
Who may be able to join
- All surviving infants born between 26 and 32 weeks gestation in our Level III NICU
Who cannot join
- Death
- Any congenital malformation
About this study
Official title: Impact of Introducing a Standardized Nutrition Protocol on Very Premature Infants' Growth and Morbidity
Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the first weeks of life is responsible for postnatal growth restriction and adverse long-term outcomes.
This study aimed at evaluating the impact of the introduction of an updated, standardized, nutrition protocol on very premature infants' growth and morbidity, and the care givers' compliance to the new protocol.
- Being tested
- nutrition protocol introduction
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition protocol introductionOther
Growth comparison of 2 cohorts of infants evaluated in a before-after design
| Study group | Role | What they receive |
|---|---|---|
| Before Protocol | 72 premature infants born between 26 and 32 weeks gestation, over 6 months period, and involved before the introduction of a strict nutrition protocol Receives: Other: nutrition protocol introduction | |
| After Protocol | 86 premature infants born between 26 and 32 weeks gestation, over 6 months period, and involved after the introduction of a strict nutrition protocol and a washout period of 6 months Receives: Other: nutrition protocol introduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
longitudinal weight evaluation
Measured: weekly recording from Day 0 up to Day 77
Secondary outcomes (6)
Necrotizing enterocolitis
Necrotizing enterocolitis
Measured: Day 77 postnatal age
late onset sepsis
Incidence of late onset sepsis
Measured: Day 77 postnatal age
patent ductus arteriosus
Incidence of patent ductus aretriosus requiring treatment
Measured: Day 77 postnatal age
Bronchopulmonary dysplasia
Incidence of Bronchopulmonary dysplasia
Measured: Day 77 postnatal age
Central venous catheters.
Duration of central venous catheters
Measured: Day 77 postnatal age
Compliance to the protocol
comparison between expected prescription and actual nutrition intake
Measured: weekly recording from Day 0 up to Day 77
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 May 2013
- Primary completion31 Oct 2014
- Study completion1 Apr 2017
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 Premature InfantsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217045
- Sponsor's protocol ID
- R2015-1
- Acronym
- Nutriproto
- Status last verified
- Feb 2023
- First submitted
- 12 Jul 2017
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wittwer A, Hascoet JM. Impact of introducing a standardized nutrition protocol on very premature infants' growth and morbidity. PLoS One. 2020 May 21;15(5):e0232659. doi: 10.1371/journal.pone.0232659. eCollection 2020.
PubMed 32437423
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Introducing a Standardized Nutrition Protocol on Very Premature Infants' Growth and Morbidity
- ClinicalTrials.gov ID
- NCT03217045
- Acronym / sponsor ID
- Nutriproto / R2015-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 31 Oct 2014 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 13 Jul 2017 (actual)
- 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.
Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the first weeks of life is responsible for postnatal growth restriction and adverse long-term outcomes.
This study aimed at evaluating the impact of the introduction of an updated, standardized, nutrition protocol on very premature infants' growth and morbidity, and the care givers' compliance to the new protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before Protocol | – | Other: nutrition protocol introduction72 premature infants born between 26 and 32 weeks gestation, over 6 months period, and involved before the introduction of a strict nutrition protocol |
| After Protocol | – | Other: nutrition protocol introduction86 premature infants born between 26 and 32 weeks gestation, over 6 months period, and involved after the introduction of a strict nutrition protocol and a washout period of 6 months |
Who may qualify
- Ages
- 1 day to 77 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All infants born between 26 to 32 weeks gestation and admitted to our level III NICU were eligible and included in the study
Key inclusion criteria (1 listed)
- All surviving infants born between 26 and 32 weeks gestation in our Level III NICU
Key exclusion criteria (2 listed)
- Death
- Any congenital malformation
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 |
|---|---|---|
| nutrition protocol introductionGrowth comparison of 2 cohorts of infants evaluated in a before-after design | Other | After Protocol, Before Protocol |
Primary outcome
weight
Time frame: weekly recording from Day 0 up to Day 77
longitudinal weight evaluation
6 secondary outcomes
Necrotizing enterocolitis
Time frame: Day 77 postnatal age
late onset sepsis
Time frame: Day 77 postnatal age
patent ductus arteriosus
Time frame: Day 77 postnatal age
Bronchopulmonary dysplasia
Time frame: Day 77 postnatal age
Central venous catheters.
Time frame: Day 77 postnatal age
Compliance to the protocol
Time frame: weekly recording from Day 0 up to Day 77
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 15 Feb 2023.
- Derived from this study: PubMed 32437423Wittwer A, Hascoet JM. Impact of introducing a standardized nutrition protocol on very premature infants' growth and morbidity. PLoS One. 2020 May 21;15(5):e0232659. doi: 10.1371/journal.pone.0232659. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infants and Nutrition Deficiency Due to Insufficient Food, run by Central Hospital, Nancy, France.
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 1 inclusion and 2 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
weight (time frame: weekly recording from Day 0 up to Day 77). 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 NCT03217045, 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 15 Feb 2023.