Skip to content

Personalised Nutrition for the Preterm Infant

Personalised Nutrition for the Preterm Infant

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07051122
Acronym
Pinpoint
Enrollment
72
Registered
2025-07-03
Start date
2018-09-01
Completion date
2020-10-31
Last updated
2025-07-03

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

Conditions

Preterm Infant Nutrition

Keywords

Nutrition, nutrient, preterm infant nutrition, preterm

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.

Interventions

None listed

Sponsors

University College Cork
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 34 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Nutrient deliveryFrom enrolment up to 10 weeksTotal 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

MeasureTime frameDescription
Infant weightFrom enrolment to 6 months corrected ageInfant weight in grammes
Infant lengthFrom enrolment to 6 months corrected agesupine length in centimetres

Other

MeasureTime frameDescription
Electroencephalogram (EEG)From enrolment to 6 months corrected ageQuantitative Electroencephalogram (EEG) features recorded during sleep divided into four groups: EEG magnitude, spectral distribution, continuity, and connectivity.
Nutritional status of vitamin DFrom enrolment for 10 weeksLaboratory analysis of microsamples of serum for markers of vitamin D metabolism (25(OH)D in nmol/L)
Neurological developmentFrom enrolment to 6 months corrected ageGriffiths Scales of Child Development, Third Edition analysis of overall general development (GD) and five neurodevelopmental areas: foundations of learning (A), language and communication (B), eye and hand coordination (C), personal-social-emotional (D), and gross motor abilities (E), with lower scores indicating more severe developmental delay.
Nutritional status of ironFrom enrolment to 10 weeksLaboratory analysis of serum ferritin (microg/L)
Body CompositionFrom enrolment to 6 months corrected ageFat mass and fat free mass by air displacement plethysmography in grammes

Countries

Ireland

Outcome results

None listed

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