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Effect of Intensive Dietary Intervention in Children With Birth Weight Between 1500 and 2000 g

Growth and Development of Premature Babies

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02833818
Acronym
CAKE
Enrollment
200
Registered
2016-07-14
Start date
2010-10-31
Completion date
2022-02-20
Last updated
2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Disorders of Growth and Development

Brief 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 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

Interventions

DIETARY_SUPPLEMENTCAKE-intervention

Increased protein and energy supplementation and conversations

DIETARY_SUPPLEMENTCAKE-control

nutrition according to established procedures

Sponsors

Elin Wahl Blakstad
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
26 Weeks to 35 Weeks
Healthy volunteers
No

Inclusion criteria

1. Birth weight between 1500 and 2000g. 2. No invasive catheters or ventilator (wish homogeneous group). 3. No malformations or chromosomal disorders. 4. Parents give informed written consent 5. Born at study hospitals

Exclusion criteria

1. Birth weight below 1500 and above 2000g. 2. Invasive catheters or ventilator. 3. Malformations or chromosomal disorders.

Design outcomes

Primary

MeasureTime frameDescription
Growth at 4 months corrected months ageFrom 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 PMAFrom birth until 4 months PMAEating habits at discharge/term and at 4 months PMA .

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026