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Long-term follow up of growth and bone mineralization of former preterm infants


- candidate number19646
- NTR NumberNTR4842
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-okt-2014
- Secondary IDs2013/594 METC
- Public TitleLong-term follow up of growth and bone mineralization of former preterm infants
- Scientific TitleLong-term follow up of growth and bone mineralization of former preterm infants
- ACRONYMFoBoMin
- hypothesisPreterm infants have a reduced length and bone density in later life compared to peers born at term. In our study we want to determine if preterm infants with different intake of calcium and phosphate in the neonatal period, have a difference in bone mineralization and length at the age of 8-10 years.
We hypothesize that the former preterm infants, with higher intake of calcium and phosphate have an improved bone mineralization and length compared to the preterm infants with less intake of calcium and phosphate.
- Healt Condition(s) or Problem(s) studiedPreterm birth, Bone density, Bone mineral density (BMD), Height
- Inclusion criteriaThe children who were included in a former cohort study were born during the year 2004 (68 children with the old composition of parenteral feeding) and 2005 (79 children with the new composition of parenteral feeding). They had at birth a gestational aged below 34 weeks, were admitted to our NICU of the first day of life and had an expected duration of parenteral nutrition of more than five days.
Of these former cohorts 55 respectively 60 children were seen at the follow-up at two years and these children we have invited for the current FoBoMin study.
- Exclusion criteria- Asphyxia
- Congenital malformation
- Renal or hepatic insufficiency at birth
- No follow up at 2 years of age
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 17-sep-2014
- planned closingdate17-sep-2015
- Target number of participants110
- Interventions- Questionnaire
- Anthropometric measurements
- Quantitative ultrasound
- DEXA-scan
- Primary outcomeTo determine whether increased calcium and phosphate intake (2005 group) resulted in improved Bone mineral content (BMC) and Bone mineral density (BMD) compared to the group with less calcium and phosphate intake (2004 group) at the age of 8-10 years, determined by DEXA-scan.
- Secondary outcomeTo determine whether increased perinatal calcium and phosphate intake (group 2005) compared to lower perinatal calcium and phosphate intake (group 2004) at the age of 8-10 years results in:
- improved BTT (bone-transit time= speed of sound (m/sec)) determined with QUS.
- improved length, weight, head circumference
- Timepointsjust one outpatient visit
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.E. Putten, van der
- CONTACT for SCIENTIFIC QUERIES M.E. Putten, van der
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Friso
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD7-okt-2014 - 5-nov-2014


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