FAcilitating Safe Transition to Home for Preterm Infants: an Observational Study

NCT05609305 | Active Not Recruiting

• 1 other identifier: 314885
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

Finding out what the common discharge barriers are in neonatal units will help design and develop services to facilitate safe, early discharge in preterm babies. This study will have 2 components. Retrospectively the study team will study the electronic medical records of preterm infants admitted to 20 neonatal units throughout the UK to identify the PMA at which each of the barriers to discharge are reached and identify the final discharge barrier. In a smaller-scale prospective study, the study team will investigate what is the final discharge barrier for infants admitted for neonatal care in the Royal Derby Hospital. The study team will follow up with the family, 2 weeks after discharge home, to find out if the infant has remained well and not required readmission to the hospital (information which will not be available in the electronic patient records analysed retrospectively). This will help determine whether the discharge was appropriate and safe.

Conditions

Infant, Premature, Discharge

Outcome Measures

Primary Outcomes (1)

• Final barrier to discharge home

  defined as the last to be achieved Able to maintain thermoregulation without additional support Breathing spontaneously without any caffeine (without supplemental oxygen or in supplemental oxygen (\<1L/min) with plan for home oxygen therapy) without any episodes of apnoea for at least 5 days Achieved safe oral feeding (adequate oral feeds or are ready for discharge on home NG-feeding regimen) defined as the last of the following four to be achieved, Able to maintain thermoregulation without additional support Breathing spontaneously without any caffeine (without supplemental oxygen or in supplemental oxygen (\<1L/min) with plan for home oxygen therapy) without any episodes of apnoea for at least 5 days Achieved safe oral feeding (adequate oral feeds or are ready for discharge on home NG-feeding regimen) Achieved a weight of at least 1700 grams

  01/01/2012 to 31/12/22

Secondary Outcomes (1)

• age

  01/01/2012 to 31/12/22

Interventions

Discharge OTHER

observational study, not intervention

Eligibility Criteria

• Age: 26 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All admissions from 01/01/2012 to 31/12/22 to NICU \<37 weeks

You may qualify if:

• Born at \<37 weeks' gestational age (GA)
• Admitted to neonatal care for \>48 hours
• Discharged home alive
• For prospective component:
• \*Parent or legal guardian available who can give informed consent

You may not qualify if:

• Infants with major congenital anomalies or genetic syndromes
• Infants who die before discharge home
• Infants who are transferred for continuing care outside of neonatal service before discharge home

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University Hospitals of Derby and Burton

Derby, Derbyshire, DE3 0ED, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Drainage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: November 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: August 31, 2025
• Last Updated: April 29, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)