Facilitating Safe Transition to Home for Preterm Infants - a National Database Study

NCT06284044 | Completed

• 1 other identifier: NIHR204885
• Study Type: observational
• Target: 250,000
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm infants (i.e. born before 37 completed weeks of pregnancy) often require additional care and are admitted to neonatal units. Readiness for discharge home typically requires a level of physiological maturity, such that an infant is: 1) able to breathe spontaneously without additional support; 2) able to maintain body temperature; 3) able to take all nutritional requirements orally; 4) weighs ≥1700 grams and is consistently gaining weight. Staying in the hospital longer than necessary can be detrimental to infants, stressful for families, and costly to the NHS. Reducing the length of stay by just one day would be meaningful to parents and could save the UK National Health Service (NHS) almost £25million per year. Currently little is known about whether, how long and why preterm infants stay in hospital beyond the point at which they are physiologically ready for discharge. This study will use data from babies' medical records from the whole of England and Wales to identify the age and postmenstrual age when preterm infants reach each of the physiological barriers to discharge and identify which physiological discharge barrier requires preterm infants to remain in hospital the longest. The study will quantify the difference between the time preterm infants become physiologically ready for discharge and actual discharge home and describe factors associated with extended stays.

Conditions

Premature Birth

Keywords

Discharge; Neonatal Intensive Care

Outcome Measures

Primary Outcomes (2)

• Age and postmenstrual age when each of three physiological barriers are reached

  Age (in days of life) and postmenstrual age (e.g., 35 weeks + 1 day) when each of three physiological barriers reached: 1. Breathing spontaneously without having received caffeine (used to treat apnoea) for at least 5 days 2. Achieved full oral feeding without need for intravenous or gastric feeding 3. Weight ≥1700 grams

  01 January 2016 to 31 December 2022

• Final barrier to discharge home

  The last of three physiological barriers to be surpassed

  01 January 2016 to 31 December 2022

Secondary Outcomes (1)

• Number of days in hospital after surpassing all physiological discharge barriers

  01 January 2016 to 31 December 2022

Eligibility Criteria

• Age: 22 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study population will include all infants born at \<37 weeks gestational age who are admitted to a neonatal unit in England and Wales which contributes data to the National Neonatal Research Database (NNRD).

You may qualify if:

• Infants admitted to neonatal units that contribute data to the NNRD who are:
• Born at \<37 completed weeks' gestational age
• Born from 01 January 2016 to 31 December 2022
• Admitted to neonatal care for \>48 hours
• Discharged home alive

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead

Study Sites (1)

University Hospitals of Derby and Burton

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

Related Publications (1)

• Szatkowski L, Abramson J, Tao S, Seaton SE, Dorling J, Arellano-Meza M, Harvey J, Harvey T, Ojha S. Facilitating safe transition to home for preterm infants (FAST home): Protocol for a retrospective observational study. PLoS One. 2025 Feb 11;20(2):e0318309. doi: 10.1371/journal.pone.0318309. eCollection 2025.

  PMID: 39932978 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Shalini Ojha, PhD

  University of Nottingham

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: December 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: August 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)