Preterm InfantNCT03728764
Growth and Safety of a Two-stage Feeding System in Preterm Infants
A study testing Preterm infant formula in people with Preterm Infant, run by Société des Produits Nestlé (SPN) at 4 sites in 3 countries.
Trial summary
This study evaluates the safety and suitability of the two-stage feeding system in preterm infants. Read more about this study
- Who is it for?
- Ages Up to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Preterm infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 10 Oct 2018to 15 Dec 2019
- Phase
- Interventional
- 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 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent has been obtained from the parents/legally acceptable representative (LAR).
- Infant's birth weight ≤1500 g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile and ≤90 percentile on the Fenton growth chart.
- Infant's gestational age ≥ 27 weeks and ≤ 32 weeks.
- Infant is clinically stable.
- Infants are eligible to start experimental formula within the first 5 days (≤120 hours) of life.
Who cannot join
- Parents not willing / not able to comply with the requirements of study protocol.
- Infants experiencing early onset sepsis.
- Major congenital or chromosomal abnormality known to affect growth.
- Preterm infants experiencing liver failure.
- Peri-/intra-ventricular haemorrhage.
- Infant requiring prolonged (more than 3 doses) of steroid treatment.
- Infants' participation in another interventional clinical trial.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Slovakia2 sites
University Hospital in Martin
Martin, 03659
Fakultná nemocnica s poliklinikou
Nové Zámky, 941 52
About this study
Official title: Growth and Safety of a Two-stage Feeding System in Preterm Infants: a Prospective, Non-randomized, Open-label, Single-arm Study
This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.
Read the detailed description
This open-label trial will be conducted in up to 74 preterm infants to evaluate the formula as it would typically be used in the neonatal care unit and to document the safety and suitability of the two-stage feeding system in terms of growth in comparison to recommended growth goals, feeding tolerance, biochemical parameters, and adverse event reporting.
- Conditions
- Preterm Infant
- Being tested
- Preterm infant formula
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm infant formulaOther
Preterm infants will receive Stage 1 investigative product as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive stage 2 preterm formula from when 1.8 kg of body weight is achieved until 1 month after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | Not described Receives: Other: Preterm infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth of preterm infants
Weight gain
Measured: from FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier
Secondary outcomes (10)
Other growth parameter at other time points
Changes in weight gain (in g/day)
Measured: from Pre-FEF Day 1 to FEF Day 1, and then weekly from FEF Day 1 until hospital discharge (on average 7 weeks after birth) and at 30-days PD.
Other growth parameter
Changes in length (cm)
Measured: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.
Other growth parameter
Head circumference (HC) (cm)
Measured: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.
Other growth parameter
Corresponding z-scores and changes in z-scores expressed using Fenton growth chart will be analyzed
Measured: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD ..
Feeding intake:
Neonatal unit feeding questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml)
Measured: daily between Pre-FEF day 1 and hospital discharge (on average 7 weeks after birth)
Feeding tolerance:
Tolerance to feeding regimen through neonatal unit questionnaire. Questionnaire assessing stool consistency (watery, mushysoft, runny, formed, hard); stool frequency (range from 0-20 times a day); Bloody stool (yes or no).
Measured: weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
Feeding intake:
Parent-reported questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml)
Measured: Daily during 30 days after hospital discharge
Feeding tolerance:
Tolerance to feeding through parent-reported questionnaire. Questionnaire assessing stool consistency (watery, mushysoft, runny, formed, hard); stool frequency (range from 0-20 times a day); Bloody stool (yes or no).
Measured: during the three days prior to the 30-day PD visit
Neonatal unit routine blood collection for safety assessment (serum blood levels of blood urea nitrogen (BUN), creatinine, albumin, pre albumin)
Clinical abnormal values will be captured as part of adverse event reporting.
Measured: will be obtained at Enrolment (baseline), if possible, Pre-FEF Day 1, FEF Day1, thereafter weekly until hospital discharge (on average 7 weeks after birth)., and lastly at 30 days post-discharge.
Number of AEs reported for safety assessment
through investigator-confirmed AE reporting
Measured: from the time the mother has consented to the infant's participation in the study soon after birth but no later than 5 days of age after birth until the 30 days PD visit in the clinic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start10 Oct 2018
- Primary completion19 Sep 2019
- Study completion15 Dec 2019
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 Preterm InfantStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728764
- Sponsor's protocol ID
- 17.14.INF
- Status last verified
- Feb 2020
- First submitted
- 2 Aug 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwinta P, Lazarova S, Demova K, Chen Y, Hartweg M, Krattinger LF, Fumero C, Buczynska A, Durlak W, Uhrikova Z, Kozar M, Samuel TM, Zibolen M. Effects of two-stage preterm formulas on growth, nutritional biomarkers, and neurodevelopment in preterm infants. Front Pediatr. 2024 Nov 22;12:1427050. doi: 10.3389/fped.2024.1427050. eCollection 2024.
PubMed 39649400
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Safety of a Two-stage Feeding System in Preterm Infants: a Prospective, Non-randomized, Open-label, Single-arm Study
- ClinicalTrials.gov ID
- NCT03728764
- Acronym / sponsor ID
- 17.14.INF
- Conditions
- Preterm Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 2 Nov 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.
This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.
Detailed description
This open-label trial will be conducted in up to 74 preterm infants to evaluate the formula as it would typically be used in the neonatal care unit and to document the safety and suitability of the two-stage feeding system in terms of growth in comparison to recommended growth goals, feeding tolerance, biochemical parameters, and adverse event reporting.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Other: Preterm infant formula |
Who may qualify
- Ages
- Up to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Written informed consent has been obtained from the parents/legally acceptable representative (LAR).
- Infant's birth weight ≤1500 g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile and ≤90 percentile on the Fenton growth chart.
- Infant's gestational age ≥ 27 weeks and ≤ 32 weeks.
- Infant is clinically stable.
- Infants are eligible to start experimental formula within the first 5 days (≤120 hours) of life.
Key exclusion criteria (7 listed)
- Parents not willing / not able to comply with the requirements of study protocol.
- Infants experiencing early onset sepsis.
- Major congenital or chromosomal abnormality known to affect growth.
- Preterm infants experiencing liver failure.
- Peri-/intra-ventricular haemorrhage.
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 |
|---|---|---|
| Preterm infant formulaPreterm infants will receive Stage 1 investigative product as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive stage 2 preterm formula from when 1.8 kg of body weight is achieved until 1 month after hospital discharge. | Other | single arm |
Primary outcome
Growth of preterm infants
Time frame: from FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier
Weight gain
10 secondary outcomes
Other growth parameter at other time points
Time frame: from Pre-FEF Day 1 to FEF Day 1, and then weekly from FEF Day 1 until hospital discharge (on average 7 weeks after birth) and at 30-days PD.
Other growth parameter
Time frame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.
Other growth parameter
Time frame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.
Other growth parameter
Time frame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD ..
Feeding intake:
Time frame: daily between Pre-FEF day 1 and hospital discharge (on average 7 weeks after birth)
Feeding tolerance:
Time frame: weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
Feeding intake:
Time frame: Daily during 30 days after hospital discharge
Feeding tolerance:
Time frame: during the three days prior to the 30-day PD visit
Neonatal unit routine blood collection for safety assessment (serum blood levels of blood urea nitrogen (BUN), creatinine, albumin, pre albumin)
Time frame: will be obtained at Enrolment (baseline), if possible, Pre-FEF Day 1, FEF Day1, thereafter weekly until hospital discharge (on average 7 weeks after birth)., and lastly at 30 days post-discharge.
Number of AEs reported for safety assessment
Time frame: from the time the mother has consented to the infant's participation in the study soon after birth but no later than 5 days of age after birth until the 30 days PD visit in the clinic.
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 25 Feb 2020.
- Derived from this study: PubMed 39649400Kwinta P, Lazarova S, Demova K, Chen Y, Hartweg M, Krattinger LF, Fumero C, Buczynska A, Durlak W, Uhrikova Z, Kozar M, Samuel TM, Zibolen M. Effects of two-stage preterm formulas on growth, nutritional biomarkers, and neurodevelopment in preterm infants. Front Pediatr. 2024 Nov 22;12:1427050. doi: 10.3389/fped.2024.1427050. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Preterm Infant
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preterm infant formula in people with Preterm Infant, run by Société des Produits Nestlé (SPN) at 4 sites in 3 countries.
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 7 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Slovakia, Czechia, Poland. 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?
Growth of preterm infants (time frame: from FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier). 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 NCT03728764, 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 25 Feb 2020.