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Completed

NCT Number: NCT07051122

Personalised Nutrition for the Preterm Infant

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.

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Key information

Age range

Up to 34 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Cork University Maternity Hospital, Infant Research Centre, University College Cork

Cork, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Nutrient delivery

    Time frame: 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 outcomes

  1. Infant weight

    Time frame: From enrolment to 6 months corrected age

    Infant weight in grammes

  2. Infant length

    Time frame: From enrolment to 6 months corrected age

    supine length in centimetres

Other outcomes

  1. Nutritional status of vitamin D

    Time frame: From enrolment for 10 weeks

    Laboratory analysis of microsamples of serum for markers of vitamin D metabolism (25(OH)D in nmol/L)

  2. Nutritional status of iron

    Time frame: From enrolment to 10 weeks

    Laboratory analysis of serum ferritin (microg/L)

  3. Body Composition

    Time frame: From enrolment to 6 months corrected age

    Fat mass and fat free mass by air displacement plethysmography in grammes

  4. Electroencephalogram (EEG)

    Time frame: From enrolment to 6 months corrected age

    Quantitative Electroencephalogram (EEG) features recorded during sleep divided into four groups: EEG magnitude, spectral distribution, continuity, and connectivity.

  5. Neurological development

    Time frame: From enrolment to 6 months corrected age

    Griffiths 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.

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Acronym: Pinpoint

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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