Premature BirthPROTSUPNCT02515266
Additional Protein Fortification in Extremely Low Birth Weight Infants
An observational study of Premature Birth and Infant, Extremely Low Birth Weight, run by Hôpital de la Croix-Rousse.
Trial summary
Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Optimal nutritional care is required to reduce the initial weight loss and further growth deficit. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Premature Birth, Infant, Extremely Low Birth Weight, Growth Failure
- What is being tested?
- nutrition: protein intake
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 2015
- 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 Up to 4 months
- All sexes
- No healthy volunteers
- Child
Study population: Premature infants weighing <1250 g at birth, who were exclusively fed with fortified HM and received additional proteinfortification for >12 consecutive days.
Who may be able to join
- infants weighing <1250 g at birth
- exclusively fed with fortified HM
Who cannot join
- Severe malformations
About this study
Official title: Evaluation of Additional Protein Fortification in Extremely Low Birth Weight Infants Fed Human Milk: PROTSUP Study
Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Optimal nutritional care is required to reduce the initial weight loss and further growth deficit.
The quantitative objective is to achieve growth that is at least equivalent to that of the fetus (on average 15 g/kg.day (12-18 g/kg.day according to gestational age). Children often grow during difficult 10-15 first days of life, so they accumulate a delay that should compensate them secondarily. Therefore, optimum postnatal growth is rather 20 g/kg.day than 15 g/kg.day.
Read more
Individualized fortification of human milk (HM) has been proposed to optimize postnatal growth. Specifically, the lack of protein intake is responsible for sub-optimal postnatal growth in preterm infants.
The objectives of this study are to determine the effectiveness of additional protein fortification (APF) in terms of short-term growth along with the proportion of extremely low birth weight (ELBW) infants requiring APF.
Read the detailed description
In a retrospective, single-center study, premature infants weighing <1250 g at birth hospitalized in investigators' neonatal intensive care unit in 2012, who were exclusively fed with fortified HM and received APF for >12 consecutive days were included.
Weight gain (g/kg•d) over the previous 7 days was calculated daily based on weight data in patients' electronic medical records. When weight gain was considered insufficient (i.e., below 20 g/kg•d) and the serum urea level was <3 mmol/L, 1 g/kg•d protein was added. Before using the mixture, investigators verified that the osmolality was only slightly increased (from 412 to 422 mOsm/kg).
Growth and digestive tolerance were compared between the week before (Wk0) and 1 and 2 weeks after (Wk1 and Wk2, respectively) the introduction of protein supplement; each participant served as his own control. Change from baseline for body weight was the main outcome. Energy and protein intake during Wk0, Wk1, and Wk2 were calculated. Standard deviation z-scores for growth parameters were calculated 7 days before, at time of protein introduction, and 7 and 14 days after . Changes in Z-scores were calculated. The digestive tolerance score and metabolic tolerance (serum urea) were assessed during Wk0, Wk1, and Wk2 (5).
- Being tested
- nutrition: protein intake
- Keywords
- protein, growth, head circumference
- Medical subject headings
- Premature Birth, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition: protein intakeOther
additional protein fortification of human milk
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body weight z-scores to 1 and 2 weeks after additional protein fortification
Measured: One and two weeks after the beginning of additional protein fortification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
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 BirthStudies 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
- 152 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, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515266
- Sponsor's protocol ID
- 20121
- Acronym
- PROTSUP
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2015
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Picaud JC, Houeto N, Buffin R, Loys CM, Godbert I, Hays S. Additional Protein Fortification Is Necessary in Extremely Low-Birth-Weight Infants Fed Human Milk. J Pediatr Gastroenterol Nutr. 2016 Jul;63(1):103-5. doi: 10.1097/MPG.0000000000001142.
PubMed 26859094
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Additional Protein Fortification in Extremely Low Birth Weight Infants Fed Human Milk: PROTSUP Study
- ClinicalTrials.gov ID
- NCT02515266
- Acronym / sponsor ID
- PROTSUP / 20121
- Keywords
- protein, growth, head circumference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hôpital de la Croix-RousseUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Aug 2015 (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.
Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Optimal nutritional care is required to reduce the initial weight loss and further growth deficit.
The quantitative objective is to achieve growth that is at least equivalent to that of the fetus (on average 15 g/kg.day (12-18 g/kg.day according to gestational age). Children often grow during difficult 10-15 first days of life, so they accumulate a delay that should compensate them secondarily. Therefore, optimum postnatal growth is rather 20 g/kg.day than 15 g/kg.day.
Individualized fortification of human milk (HM) has been proposed to optimize postnatal growth. Specifically, the lack of protein intake is responsible for sub-optimal postnatal growth in preterm infants.
The objectives of this study are to determine the effectiveness of additional protein fortification (APF) in terms of short-term growth along with the proportion of extremely low birth weight (ELBW) infants requiring APF.
Detailed description
In a retrospective, single-center study, premature infants weighing <1250 g at birth hospitalized in investigators' neonatal intensive care unit in 2012, who were exclusively fed with fortified HM and received APF for >12 consecutive days were included.
Weight gain (g/kg•d) over the previous 7 days was calculated daily based on weight data in patients' electronic medical records. When weight gain was considered insufficient (i.e., below 20 g/kg•d) and the serum urea level was <3 mmol/L, 1 g/kg•d protein was added. Before using the mixture, investigators verified that the osmolality was only slightly increased (from 412 to 422 mOsm/kg).
Growth and digestive tolerance were compared between the week before (Wk0) and 1 and 2 weeks after (Wk1 and Wk2, respectively) the introduction of protein supplement; each participant served as his own control. Change from baseline for body weight was the main outcome. Energy and protein intake during Wk0, Wk1, and Wk2 were calculated. Standard deviation z-scores for growth parameters were calculated 7 days before, at time of protein introduction, and 7 and 14 days after . Changes in Z-scores were calculated. The digestive tolerance score and metabolic tolerance (serum urea) were assessed during Wk0, Wk1, and Wk2 (5).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature infants weighing <1250 g at birth, who were exclusively fed with fortified HM and received additional proteinfortification for >12 consecutive days.
Key inclusion criteria (2 listed)
- infants weighing <1250 g at birth
- exclusively fed with fortified HM
Key exclusion criteria (1 listed)
- Severe malformations
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: protein intakeadditional protein fortification of human milk | Other | – |
Primary outcome
Change from baseline body weight z-scores to 1 and 2 weeks after additional protein fortification
Time frame: One and two weeks after the beginning of additional protein fortification
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 4 Aug 2015.
- Derived from this study: PubMed 26859094Picaud JC, Houeto N, Buffin R, Loys CM, Godbert I, Hays S. Additional Protein Fortification Is Necessary in Extremely Low-Birth-Weight Infants Fed Human Milk. J Pediatr Gastroenterol Nutr. 2016 Jul;63(1):103-5. doi: 10.1097/MPG.0000000000001142.
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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 study director
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Infant, Extremely Low Birth Weight, run by Hôpital de la Croix-Rousse.
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 2 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 4 Aug 2015. 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?
Change from baseline body weight z-scores to 1 and 2 weeks after additional protein fortification (time frame: One and two weeks after the beginning of additional protein fortification). 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 NCT02515266, 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 4 Aug 2015.