Personalised Nutrition for the Preterm Infant
- Conditions
- Preterm Infant Nutrition
- Registration Number
- NCT07051122
- Lead Sponsor
- University College Cork
- Brief Summary
The aim of the Pinpoint observational study is to collect nutrition and health data in a cohort of preterm, low birth weight infants to investigate if their nutrition support is adequate. Results will inform nutritional requirements and monitoring of preterm infants for macronutrients and micronutrients.
- Detailed Description
Background The goal of neonatal nutrition in the preterm infant is to achieve postnatal growth and body composition approximating that of a normal fetus of the same postmenstrual age and to obtain a functional outcome comparable to infants born at term. While international consensus guidelines for the nutritional management of preterm infants have been formulated, gaps between these nutrition guidelines and clinical practice have been extensively reported, resulting in nutritional deficits and inadequate growth and development.
A previous study of preterm infants (NCT01881256), showed that despite best practice guidelines, infants did not receive sufficient energy and protein to meet recommendations, which contributed to early growth failure. While some recent progress has been made in the field, with studies demonstrating reductions in cumulative nutrient deficits and improvements in growth after the optimisation of nutritional protocols, uncertainties still remain as to the nutritional requirements of preterm infants and how best to meet them. The nutritional management of preterm infants is complicated by their complex nutritional needs and different sources of nutrients as they progress through the neonatal course.
Challenge A major drawback is the lack of real-time feedback data on actual daily nutrient intakes of infants in the neonatal unit. Without this precise information, nutritional management is based on estimates, which can lead to nutritional deficits. The consequences of missed opportunities for optimal nutrient delivery may be far-reaching, in terms of inadequate growth and suboptimal developmental outcomes. Enhanced nutritional data collection and monitoring at the infant's cot-side in the neonatal unit would support more effective clinical decision-making, resulting in improved outcomes for infants.
Objective To collect extensive data on nutrition and health in preterm, low birth weight infants to inform development of bespoke software to track nutrient delivery in the neonatal unit. To describe relationships between nutrient delivery and nutritional status of iron and vitamin D and to analyse the impact of revised nutritional recommendations on nutrition and growth.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Gestational age <34 weeks
- Birth weight ≤1800g
- Parents/legally authorised representative provides signed and dated informed proxy consent within 48 hours of infant's birth.
• Infants born with life-threatening congenital or chromosomal abnormalities.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Nutrient delivery From enrolment up to 10 weeks Total energy, macronutrient and micronutrient delivery from all sources, including parenteral and enteral nutrition and nutritional supplements will be collected and analysed in MC Excel and our bespoke preterm nutrition software to calculate individual energy, macronutrient and micronutrient intakes (on a daily basis) for comparison with historical data and international recommendations.
- Secondary Outcome Measures
Name Time Method Infant weight From enrolment to 6 months corrected age Infant weight in grammes
Infant length From enrolment to 6 months corrected age supine length in centimetres
Trial Locations
- Locations (1)
Cork University Maternity Hospital, Infant Research Centre, University College Cork
🇮🇪Cork, Ireland
Cork University Maternity Hospital, Infant Research Centre, University College Cork🇮🇪Cork, Ireland