Personalised Nutrition for the Preterm Infant (Pinpoint)

University College Cork (UCC)

Status: Completed

Conditions: Preterm Infant Nutrition

Study type: Observational

Funder types: Other

Identifiers

NCT07051122

Pinpoint

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: Under 34 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Infants born with life-threatening congenital or chromosomal abnormalities.

Trial design

72 participants in 1 patient group

Preterm infants

Description:

* Gestational age \<34 weeks * Birth weight ≤1800g