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other·pediatrics, pediatric ophthalmology, neurology, nutrition, clinical trial·PMC10121423

Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol

Trials · 7 authors, 8 centres

AI SUMMARY

FIDELITY 100%

POPULATIONPreterm infants born before 29 weeks postmenstrual age and/or with a birth weight of less than 1250 g, discharged from the hospital (n=334 planned).

INTERVENTIONSmell and taste of milk with each tube feed.

COMPARISONRoutine care.

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

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TL;DR

This is a protocol for a 2-year neurodevelopmental follow-up of a randomized trial in preterm infants, designed to assess whether early smell and taste exposure during tube feeding improves long-term outcomes.

Full summary

652 CHARS

The original trial randomized preterm infants to receive smell and taste of milk with tube feeds versus routine care. The primary outcome for this follow-up is survival free of major neurodevelopmental impairment at 2 years corrected age, defined by specific criteria for cerebral palsy, Bayley Scales scores, blindness, or deafness. Statistical analysis will use multiple imputation for missing data and generalized estimating equations. The protocol acknowledges significant anticipated limitations due to the COVID-19 pandemic, which caused disruptions to follow-up visits and may lead to missing data, attrition bias, and reduced statistical power.

PICO

PPOPULATION

Preterm infants born before 29 weeks postmenstrual age and/or with a birth weight of less than 1250 g, discharged from the hospital (n=334 planned).

IINTERVENTION

Smell and taste of milk with each tube feed.

OOUTCOME

Survival free of any major neurodevelopmental impairment (primary), and secondary outcomes including death, growth, feeding, and respiratory support at 2 years.

STUDY TYPE

other

SPECIALTY

pediatrics

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10121423

Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol

Trials

READ THE FULL PAPER

ABSTRACT

Abstract Background The Taste And Smell To Enhance nutrition (TASTE) trial investigated the effects of smell and taste of milk with tube feeding compared to routine care on the growth of preterm infants. There was no difference between groups in growth (weight, head circumference, length) z -scores at discharge from the hospital. Infants in the intervention group had higher head circumference and length z -scores at 36 weeks postmenstrual age, both secondary outcomes. The objective of this follow-up study is to assess 2-year neurodevelopmental and growth outcomes after exposure of preterm infants to the smell and taste of milk with tube feeding compared to routine care. Methods This is a neurodevelopmental follow-up study of a two-center, placebo-controlled randomized trial. Infants born before 29 weeks postmenstrual age and/or with a birth weight of less than 1250 g were randomized to smell and taste of milk with each tube feed or routine care. The current follow-up assessed the 2-year neurodevelopmental and growth outcomes of participants of the TASTE trial discharged from the hospital ( n = 334). The primary outcome is survival free of any major neurodevelopmental impairment comprising any moderate/severe cerebral palsy (Gross Motor Function Classification System score II–V), Bayley Scales of Infant and Toddler Development, Third/Fourth Edition (Bayley-III/Bayley-4) motor, cognitive, or language scores < -2SD, blindness, or deafness at 2 years of age. Other outcomes include death, breastfeeding within the first year, and respiratory support, oral feeding, and anthropometric parameters at 2 years of age. The Human Research Ethics Committees of Mater Misericordiae Limited and the Royal Women’s Hospital approved the TASTE trial including the neurodevelopmental follow-up described in this protocol. Discussion For patients and their families, the neurodevelopmental outcomes of preterm infants are of utmost importance. Consequently, they should be investigated following any interventional study performed during the newborn period. Furthermore, improved weight gain and head growth in the hospital are associated with better long-term neurodevelopmental outcomes. Smelling and tasting of milk is an uncomplicated and cost-effective intervention that may improve the growth and neurodevelopmental outcomes of preterm infants. Potential limitations affecting this follow-up study, caused by the COVID-19 pandemic, are anticipated and discussed in this protocol. Trial registration Name of the registry: Australian and New Zealand Clinical Trials Registry; Registration number: ACTRN12617000583347 ; Registration date: 26 April 2017. Keyword: Bayley-4, Early nutritional learning, Follow-up, Neurodevelopment, Preterm

CITATION EXPORT

Friederike Beker, Ian P Hughes, Sue Jacobs et al.. Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol. Trials. (2023). https://doi.org/10.1186/s13063-023-07224-0

AUTHORS

7 · 8 CENTRES

Friederike Beker, Ian P Hughes, Sue Jacobs, Helen G Liley, Samudragupta Bora, Gabrielle Simcock, Peter G Davis

1Mater Research Institute, Faculty of Medicine, The University of Queensland, South Brisbane, Queensland Australia
2Neonatal Critical Care Unit, Mater Mothers’ Hospitals, South Brisbane, Queensland Australia
3Office of Research Governance and Development, Gold Coast University Hospital, Southport, Queensland Australia
4Neonatal Services and Newborn Research, The Royal Women’s Hospital, Melbourne, Victoria Australia
5Clinical Sciences Research, Murdoch Children’s Research Institute, Parkville, Victoria Australia
6Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria Australia
7Department of Pediatrics, University Hospitals Rainbow Babies & Children’s Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio USA
8School of Applied Psychology, Griffith University, Southport, Queensland Australia