NCT07051122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

June 19, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

Nutritionnutrientpreterm infant nutritionpreterm

Outcome Measures

Primary Outcomes (1)

  • Nutrient delivery

    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.

    From enrolment up to 10 weeks

Secondary Outcomes (2)

  • Infant weight

    From enrolment to 6 months corrected age

  • Infant length

    From enrolment to 6 months corrected age

Other Outcomes (5)

  • Nutritional status of vitamin D

    From enrolment for 10 weeks

  • Nutritional status of iron

    From enrolment to 10 weeks

  • Body Composition

    From enrolment to 6 months corrected age

  • +2 more other outcomes

Study Arms (1)

Preterm infants

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

Eligibility Criteria

AgeUp to 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm infants born less than 34 weeks of gestation and under 1800 g birth weight

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cork, Ireland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2025

First Posted

July 3, 2025

Study Start

September 1, 2018

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

These data were collected in a vulnerable and heterogenous population. The consent provided by parents did not include data sharing.

Locations