Prematurity; ExtremeKARLYNCT03635944
Nutritional Care and Head Growth in Preterm Infants
An observational study of Prematurity; Extreme and Growth Retardation, run by Hôpital de la Croix-Rousse at 1 site in France.
Trial summary
As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units. A retrospective study included extremely low birth weight infants born in Lyon, France or in Stockholm, Sweden. Read more about this study
- Who is it for?
- Ages 1 minute to 6 months
- Conditions the study is for
- Prematurity; Extreme, Growth Retardation
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2016to 1 Jul 2018
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Extremely low birth weight infants born in two European tertiary care centres: neonatal unit of Croix Rousse Hospital in Lyon, France and the neonatal unit of Astrid Lindgren Children's Hospital in Stockholm, Sweden
Who may be able to join
- birth weight under 1000 grams
- gestational age (GA) between 23 and 28 weeks
- born in 2012
- admitted during the first 24 hours of life
- stayed in one of the two studied units for at least 7 weeks before transfer to the referring hospital, discharge to home or death.
Who cannot join
- Neonates with congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Care Influences Head Growth at Discharge in Extremely Low Birth Weight Infants.
As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units. A retrospective study included extremely low birth weight infants born in Lyon, France or in Stockholm, Sweden. Data on morbidity, treatments, care practices, macro-nutrient intakes and postnatal growth were collected to determine risk factors of extra uterine growth restriction at discharge.
By comparing postnatal growth in ELBW infants hospitalized in two European neonatal intensive care units with different nutritional and extra nutritional care,our objective was to evaluate the role of nutrition in this population of preterm infants.
Read the detailed description
In a retrospective study, all ELBW infants (birth weight under 1000 g) with a gestational age between 23 and 28 weeks were included if they were admitted during the first 24 hours of life and stayed for at least seven weeks in two European units (Lyon, france, and Stockholm, Sweden). Parenteral and enteral nutrition policies were detailed and protein and energy intakes were collected.Growth assessment Postnatal growth was precisely evaluated and compared in the two groups of infants.
Body weight, crown-heel length and head circumference were measured in both units at birth and until discharge. We calculated z-scores and changes in z-scores between birth and 36 weeks post-conceptional age (delta z-score) for body weight, HC, and crown-to-heel length using Olsen's references. Intra-uterine growth restriction was defined as a birth weight below or equal to minus two standard deviations. Extra-uterine growth restriction was defined as a z-score loss above or equal one standard deviation between birth and 36 weeks PCA. I
- Conditions
- Prematurity; Extreme, Growth Retardation
- Keywords
- growth, small for gestational age, prematurity, breastfeeding, fortification, parenteral nutrition, nutrition
- Medical subject headings
- Premature Birth, Breast Feeding, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Infants born in Lyon (France) | |
| Group B | Infants born in Stockholm (Sweden) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain during hospitalization
difference in weight between birth and discharge
Measured: between birth and 40 weeks
Secondary outcomes (2)
Crown-heel length gain during hospitalization
difference in recumbent length between birth and discharge
Measured: between birth and 40 weeks
Head circumference gain during hospitalization
difference in head circumference between birth and discharge
Measured: between birth and 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Dec 2016
- Primary completion1 May 2017
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity; ExtremeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital de la Croix-Rousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-charles PICAUD, MD, PhD, Hôpital de la Croix-Rousse
- Investigators
- jean-charles picaud, MD, PhD, Principal investigator, Hopital de la croix rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635944
- Sponsor's protocol ID
- PICAUD JC
- Acronym
- KARLY
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Care Influences Head Growth at Discharge in Extremely Low Birth Weight Infants.
- ClinicalTrials.gov ID
- NCT03635944
- Acronym / sponsor ID
- KARLY / PICAUD JC
- Conditions
- Prematurity; Extreme, Growth Retardation
- Keywords
- growth, small for gestational age, prematurity, breastfeeding, fortification, parenteral nutrition, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hôpital de la Croix-RousseUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 17 Aug 2018 (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.
As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units. A retrospective study included extremely low birth weight infants born in Lyon, France or in Stockholm, Sweden. Data on morbidity, treatments, care practices, macro-nutrient intakes and postnatal growth were collected to determine risk factors of extra uterine growth restriction at discharge.
By comparing postnatal growth in ELBW infants hospitalized in two European neonatal intensive care units with different nutritional and extra nutritional care,our objective was to evaluate the role of nutrition in this population of preterm infants.
Detailed description
In a retrospective study, all ELBW infants (birth weight under 1000 g) with a gestational age between 23 and 28 weeks were included if they were admitted during the first 24 hours of life and stayed for at least seven weeks in two European units (Lyon, france, and Stockholm, Sweden). Parenteral and enteral nutrition policies were detailed and protein and energy intakes were collected.Growth assessment Postnatal growth was precisely evaluated and compared in the two groups of infants.
Body weight, crown-heel length and head circumference were measured in both units at birth and until discharge. We calculated z-scores and changes in z-scores between birth and 36 weeks post-conceptional age (delta z-score) for body weight, HC, and crown-to-heel length using Olsen's references. Intra-uterine growth restriction was defined as a birth weight below or equal to minus two standard deviations. Extra-uterine growth restriction was defined as a z-score loss above or equal one standard deviation between birth and 36 weeks PCA. I
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Infants born in Lyon (France) |
| Group B | – | –Infants born in Stockholm (Sweden) |
Who may qualify
- Ages
- 1 minute to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Extremely low birth weight infants born in two European tertiary care centres: neonatal unit of Croix Rousse Hospital in Lyon, France and the neonatal unit of Astrid Lindgren Children's Hospital in Stockholm, Sweden
Key inclusion criteria (5 listed)
- birth weight under 1000 grams
- gestational age (GA) between 23 and 28 weeks
- born in 2012
- admitted during the first 24 hours of life
- stayed in one of the two studied units for at least 7 weeks before transfer to the referring hospital, discharge to home or death.
Key exclusion criteria (1 listed)
- Neonates with congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight gain during hospitalization
Time frame: between birth and 40 weeks
difference in weight between birth and discharge
2 secondary outcomes
Crown-heel length gain during hospitalization
Time frame: between birth and 40 weeks
Head circumference gain during hospitalization
Time frame: between birth and 40 weeks
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 17 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
jean-charles picaud, MD, PhD principal investigator
Hopital de la croix rousse
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 Prematurity; Extreme and Growth Retardation, run by Hôpital de la Croix-Rousse at 1 site in 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 5 inclusion and 1 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 17 Aug 2018. 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 France. 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?
Weight gain during hospitalization (time frame: between birth and 40 weeks). 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 17 Aug 2018.