Perinatal Disorders of Growth and DevelopmentCAKENCT02833818
Effect of Intensive Dietary Intervention in Children With Birth Weight Between 1500 and 2000 g
A study testing CAKE-intervention in people with Perinatal Disorders of Growth and Development, run by Elin Wahl Blakstad.
Trial summary
There are few scientific reports on preterm infants with birth weights between 1500 and 2000g. Adequate and properly balanced supply of nutrients believed to better growth and cognitive development in this patient group, and optimized nutrition is an important part of treatment There is a need for more studies that… Read more about this study
- Who is it for?
- Ages 26 to 35 weeks
- Conditions the study is for
- Perinatal Disorders of Growth and Development
- What is being tested?
- CAKE-intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to 20 Feb 2022
- 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 26 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight between 1500 and 2000g.
- No invasive catheters or ventilator (wish homogeneous group).
- No malformations or chromosomal disorders.
- Parents give informed written consent
- Born at study hospitals
Who cannot join
- Birth weight below 1500 and above 2000g.
- Invasive catheters or ventilator.
- Malformations or chromosomal disorders.
About this study
Official title: Growth and Development of Premature Babies
There are few scientific reports on preterm infants with birth weights between 1500 and 2000g. Adequate and properly balanced supply of nutrients believed to better growth and cognitive development in this patient group, and optimized nutrition is an important part of treatment There is a need for more studies that can provide knowledge of growth and weight development in preterm and small for gestational age (SGA) infants with a birth weight between 1500 and 2000g.
Read the detailed description
There has been little focus, at least there are few scientific reports on preterm infants with birth weights between 1500 and 2000g, at least in Norway. Studies have shown the benefit of enhanced protein and energy supplements in very low birth weight infants (VLBW, birth weight < 1500g), regarding growth and neurodevelopment . Adequate and properly balanced supply of nutrients is believed to give better growth and cognitive development in premature infants with slightly higher birth weight, i.e between 1500 and 2000g (1). In an intervention study of VLBW children at four Norwegian hospitals we found lower supply of energy and protein than international recommendations (2). A larger proportion of premature children were stunted growth (weight below 10 percentile for age) during hospitalization. Although this applies to preterm infants with birth weight less than 1500 g, this may also be the case for larger premature patients.
More studies that can provide knowledge of growth rate, weight and neurodevelopmental outcomes in preterm and small for gestational age (SGA) infants are warranted. This study examines those with birth weight between 1500 and 2000g. Overall, this may provide new and useful knowledge that can help to optimize the nutrition to preterm and SGA infants with a this range of birth weights
- Being tested
- CAKE-intervention, CAKE-control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAKE-interventionDietary supplement
Also called clinical nutritionist, high protein and energy
Increased protein and energy supplementation and conversations
CAKE-controlDietary supplement
nutrition according to established procedures
| Study group | Role | What they receive |
|---|---|---|
| CAKE-intervention | Experimental | Increased nutrition and dietary consultations. Growth rate followed by clinical nutritionists that supply high protein and energy if growth rate deviates from 17g/kg/day Receives: Dietary Supplement: CAKE-intervention |
| CAKE-control | Active comparator | nutrition according to established procedures in the neonatal intensive care unit (NICU) Receives: Dietary Supplement: CAKE-control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth at 4 months corrected months age
Growth from birth, during hospital stay, at discharge/term and at 4 months PMA.
Measured: From birth until 4 months postmenstrual age (PMA)
Breastfed, full or partly, and solid food at 4 months PMA
Eating habits at discharge/term and at 4 months PMA .
Measured: From birth until 4 months PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startOct 2010
- Primary completion20 Feb 2022 (estimated)
- Study completion20 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Disorders of Growth and DevelopmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elin Wahl Blakstad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elin Wahl Blakstad, University Hospital, Akershus
- Investigators
- Britt Nakstad, PhD MD, Study director, Project leader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833818
- Sponsor's protocol ID
- AkershusUH
- Acronym
- CAKE
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2016
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Development of Premature Babies
- ClinicalTrials.gov ID
- NCT02833818
- Acronym / sponsor ID
- CAKE / AkershusUH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Elin Wahl BlakstadUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- 20 Feb 2022 (estimated)
- Study completion
- 20 Feb 2022 (estimated)
- First posted
- 14 Jul 2016 (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.
There are few scientific reports on preterm infants with birth weights between 1500 and 2000g. Adequate and properly balanced supply of nutrients believed to better growth and cognitive development in this patient group, and optimized nutrition is an important part of treatment There is a need for more studies that can provide knowledge of growth and weight development in preterm and small for gestational age (SGA) infants with a birth weight between 1500 and 2000g.
Detailed description
There has been little focus, at least there are few scientific reports on preterm infants with birth weights between 1500 and 2000g, at least in Norway. Studies have shown the benefit of enhanced protein and energy supplements in very low birth weight infants (VLBW, birth weight < 1500g), regarding growth and neurodevelopment . Adequate and properly balanced supply of nutrients is believed to give better growth and cognitive development in premature infants with slightly higher birth weight, i.e between 1500 and 2000g (1). In an intervention study of VLBW children at four Norwegian hospitals we found lower supply of energy and protein than international recommendations (2). A larger proportion of premature children were stunted growth (weight below 10 percentile for age) during hospitalization. Although this applies to preterm infants with birth weight less than 1500 g, this may also be the case for larger premature patients.
More studies that can provide knowledge of growth rate, weight and neurodevelopmental outcomes in preterm and small for gestational age (SGA) infants are warranted. This study examines those with birth weight between 1500 and 2000g. Overall, this may provide new and useful knowledge that can help to optimize the nutrition to preterm and SGA infants with a this range of birth weights
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAKE-intervention | Experimental | Dietary Supplement: CAKE-interventionIncreased nutrition and dietary consultations. Growth rate followed by clinical nutritionists that supply high protein and energy if growth rate deviates from 17g/kg/day |
| CAKE-control | Active comparator | Dietary Supplement: CAKE-controlnutrition according to established procedures in the neonatal intensive care unit (NICU) |
Who may qualify
- Ages
- 26 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Birth weight between 1500 and 2000g.
- No invasive catheters or ventilator (wish homogeneous group).
- No malformations or chromosomal disorders.
- Parents give informed written consent
- Born at study hospitals
Key exclusion criteria (3 listed)
- Birth weight below 1500 and above 2000g.
- Invasive catheters or ventilator.
- Malformations or chromosomal disorders.
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 |
|---|---|---|
| CAKE-interventionAlso: clinical nutritionist, high protein and energyIncreased protein and energy supplementation and conversations | Dietary supplement | CAKE-intervention |
| CAKE-controlnutrition according to established procedures | Dietary supplement | CAKE-control |
Primary outcome
Growth at 4 months corrected months age
Time frame: From birth until 4 months postmenstrual age (PMA)
Growth from birth, during hospital stay, at discharge/term and at 4 months PMA.
Breastfed, full or partly, and solid food at 4 months PMA
Time frame: From birth until 4 months PMA
Eating habits at discharge/term and at 4 months PMA .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- 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.
Britt Nakstad, PhD MD study director
Project leader
Questions about this trial
What is this clinical trial studying?
A study testing CAKE-intervention in people with Perinatal Disorders of Growth and Development, run by Elin Wahl Blakstad.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Feb 2021. 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?
Results are not available in the source record.
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 at 4 months corrected months age (time frame: From birth until 4 months postmenstrual age (PMA)). The study lists 2 primary outcomes in all. 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 2 Feb 2021.