Support at home for infants with feeding tubes (SHIFT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN79583069

Enrollment

100

Registered

2012-03-09

Start date

2012-05-01

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm infants Neonatal Diseases Other preterm infants

Interventions

Discharge home with a feeding tube versus standard care, which is to remain in hospital until the feeding tube is no longer needed.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Preterm infants <37 weeks gestation 2. Unable to fully orally feed 3. Able to take at least one reasonable volume/duration oral feed 4. Expected to fully orally feed within the next 2 - 4 weeks 5. No medical requirement for continuing hospitalisation 6. Signed parental consent

Exclusion criteria

Exclusion criteria: Infants with underlying problems such that tube feeding is not likely to be a temporary need (for example, brain injured infants or those with congenital abnormalities)

Design outcomes

Primary

Measure	Time frame
Infant outcome measures: 1. Growth (weight, head circumference and length) weekly until discharged from community care (or discharged home for standard care group) and then monthly to 3 months for all 2. Feeding method (exclusive breast, formula or mixed feeding) 3. Infection episodes (defined as treatment by a medical practitioner for suspected infection) 4. Re-admission rates (defined as number of episodes requiring re-hospitalisation as an in-patient) Parental measures Anxiety state/trait questionnaire administered twice ? once at the point of discharge home, and again at 3 months of corrected age. This will be measured using the Spielberger State-Trait Anxiety Inventory which is well validated and currently used in some of our other studies with parents of newborn babies. Economic data and analysis: Costings will be calculated for community nursing visits required, any additional input received from the primary care team, consumable costs (feeding tubes, syringes etc) and days of hospital care received.	—

Measure

Time frame

Infant outcome measures: 1. Growth (weight, head circumference and length) weekly until discharged from community care (or discharged home for standard care group) and then monthly to 3 months for all 2. Feeding method (exclusive breast, formula or mixed feeding) 3. Infection episodes (defined as treatment by a medical practitioner for suspected infection) 4. Re-admission rates (defined as number of episodes requiring re-hospitalisation as an in-patient) Parental measures Anxiety state/trait questionnaire administered twice ? once at the point of discharge home, and again at 3 months of corrected age. This will be measured using the Spielberger State-Trait Anxiety Inventory which is well validated and currently used in some of our other studies with parents of newborn babies. Economic data and analysis: Costings will be calculated for community nursing visits required, any additional input received from the primary care team, consumable costs (feeding tubes, syringes etc) and days of hospital care received.

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026