Premature BirthNCT06284044
Facilitating Safe Transition to Home for Preterm Infants - a National Database Study
An observational study of Premature Birth, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 36 weeks
- Conditions the study is for
- Premature Birth
- How many people
- 250,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2023to 1 Aug 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 36 weeks
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Derby and Burton
Derby, Derbyshire, DE22 3DT
About this study
Official title: Facilitating Safe Transition to Home for Preterm Infants - a Retrospective Observational Study Using a National Database
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.
Read the detailed description
Infants born preterm (i.e., before 37 completed weeks of pregnancy) often require additional care and are admitted to neonatal units. Depending on needs, preterm infants have varying lengths of hospital stay; most go home between 37 and 40 weeks' post-menstrual age. Before a preterm infant can go home, there must be a readiness for safe discharge. "Discharge readiness" typically requires a level of physiological maturity such that the infant can:
- Breathe without support: preterm babies often have breathing pauses (apnoea of prematurity); many require breathing support. With maturity, infants can breathe without support. Some may continue to need additional oxygen, and some go home on oxygen therapy.
- Maintain body temperature: initially preterm infants are nursed in incubators. As the ability to generate and preserve heat matures, infants may move into heated cots initially and then finally into regular cots with normal clothing and blankets.
- Feed adequately: preterm infants can take time to establish feeding. Initially potentially needing parenteral nutrition. Milk is slowly introduced via a gastric tube. As the ability to suck and swallow matures, infants learn to feed orally (on the breast or by bottle). To be discharged without additional support, infants need to be able to take milk requirements orally. Occasionally, where the service is available, infants can go home with partial nasogastric feeding.
- Gain weight: Most infants are considered ready if they weigh at least 1700-1800g and are consistently gaining weight.
In addition, families must be prepared to care for the infant independently (including keeping the baby warm, feeding, bathing, safe travel, and giving medicines) and be emotionally ready and confident.
Infants achieve maturity at variable pace and may become mature in some aspects but not all e.g., be able to breathe well, maintain temperature, and gain weight, but still be unable to take sufficient oral feeds. The final reason that keeps the infant in hospital is referred to as the "terminal or final discharge barrier". There is very little research to investigate the barriers to safe discharge and to find the most common "final discharge barrier" for preterm infants in the UK.
The study team will use data from the National Neonatal Research Database (NNRD) for all infants born at <37 weeks' gestational age and admitted to neonatal units in England and Wales from 2016-2022. The day of life and postmenstrual age each infant reaches each of the physiological barriers to discharge will be described, and the final 'barrier to discharge' to be reached will be identified. The study team will assess whether the final discharge barriers differ by gestational age and between neonatal units and summarise the number of days infants remain in the hospital after surpassing all physiological milestones. The study team will explore the characteristics of infants, mothers and neonatal units that are associated with extended hospital stays beyond physiological readiness for discharge.
- Conditions
- Premature Birth
- Keywords
- Discharge, Neonatal Intensive Care
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Breathing spontaneously without having received caffeine (used to treat apnoea) for at least 5 days
- Achieved full oral feeding without need for intravenous or gastric feeding
- Weight ≥1700 grams
Measured: 01 January 2016 to 31 December 2022
Final barrier to discharge home
The last of three physiological barriers to be surpassed
Measured: 01 January 2016 to 31 December 2022
Secondary outcomes (1)
Number of days in hospital after surpassing all physiological discharge barriers
Difference (in days) between reaching the last of the three physiological barriers to be reached and the day of discharge home
Measured: 01 January 2016 to 31 December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Dec 2023
- Primary completion30 Nov 2024
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250,000 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shalini Ojha, PhD, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284044
- Sponsor's protocol ID
- NIHR204885
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39932978
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Safe Transition to Home for Preterm Infants - a Retrospective Observational Study Using a National Database
- ClinicalTrials.gov ID
- NCT06284044
- Acronym / sponsor ID
- NIHR204885
- Conditions
- Premature Birth
- Keywords
- Discharge, Neonatal Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250,000 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Infants born preterm (i.e., before 37 completed weeks of pregnancy) often require additional care and are admitted to neonatal units. Depending on needs, preterm infants have varying lengths of hospital stay; most go home between 37 and 40 weeks' post-menstrual age. Before a preterm infant can go home, there must be a readiness for safe discharge. "Discharge readiness" typically requires a level of physiological maturity such that the infant can:
- Breathe without support: preterm babies often have breathing pauses (apnoea of prematurity); many require breathing support. With maturity, infants can breathe without support. Some may continue to need additional oxygen, and some go home on oxygen therapy.
- Maintain body temperature: initially preterm infants are nursed in incubators. As the ability to generate and preserve heat matures, infants may move into heated cots initially and then finally into regular cots with normal clothing and blankets.
- Feed adequately: preterm infants can take time to establish feeding. Initially potentially needing parenteral nutrition. Milk is slowly introduced via a gastric tube. As the ability to suck and swallow matures, infants learn to feed orally (on the breast or by bottle). To be discharged without additional support, infants need to be able to take milk requirements orally. Occasionally, where the service is available, infants can go home with partial nasogastric feeding.
- Gain weight: Most infants are considered ready if they weigh at least 1700-1800g and are consistently gaining weight.
In addition, families must be prepared to care for the infant independently (including keeping the baby warm, feeding, bathing, safe travel, and giving medicines) and be emotionally ready and confident.
Infants achieve maturity at variable pace and may become mature in some aspects but not all e.g., be able to breathe well, maintain temperature, and gain weight, but still be unable to take sufficient oral feeds. The final reason that keeps the infant in hospital is referred to as the "terminal or final discharge barrier". There is very little research to investigate the barriers to safe discharge and to find the most common "final discharge barrier" for preterm infants in the UK.
The study team will use data from the National Neonatal Research Database (NNRD) for all infants born at <37 weeks' gestational age and admitted to neonatal units in England and Wales from 2016-2022. The day of life and postmenstrual age each infant reaches each of the physiological barriers to discharge will be described, and the final 'barrier to discharge' to be reached will be identified. The study team will assess whether the final discharge barriers differ by gestational age and between neonatal units and summarise the number of days infants remain in the hospital after surpassing all physiological milestones. The study team will explore the characteristics of infants, mothers and neonatal units that are associated with extended hospital stays beyond physiological readiness for discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 22 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age and postmenstrual age when each of three physiological barriers are reached
Time frame: 01 January 2016 to 31 December 2022
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
Final barrier to discharge home
Time frame: 01 January 2016 to 31 December 2022
The last of three physiological barriers to be surpassed
1 secondary outcome
Number of days in hospital after surpassing all physiological discharge barriers
Time frame: 01 January 2016 to 31 December 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 39932978Szatkowski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Ojha, PhD study chair
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age and postmenstrual age when each of three physiological barriers are reached (time frame: 01 January 2016 to 31 December 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.