Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol
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 a...
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| Format: | Article |
| Language: | English |
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BMC
2023-04-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07224-0 |
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| author | Friederike Beker Ian P. Hughes Sue Jacobs Helen G. Liley Samudragupta Bora Gabrielle Simcock Peter G. Davis |
| author_facet | Friederike Beker Ian P. Hughes Sue Jacobs Helen G. Liley Samudragupta Bora Gabrielle Simcock Peter G. Davis |
| author_sort | Friederike Beker |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T16:21:22Z |
| format | Article |
| id | doaj.art-405b171827d941128fc376378ac6c5bc |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T16:21:22Z |
| publishDate | 2023-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-405b171827d941128fc376378ac6c5bc2023-04-23T11:27:10ZengBMCTrials1745-62152023-04-012411610.1186/s13063-023-07224-0Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocolFriederike Beker0Ian P. Hughes1Sue Jacobs2Helen G. Liley3Samudragupta Bora4Gabrielle Simcock5Peter G. Davis6Mater Research Institute, Faculty of Medicine, The University of QueenslandOffice of Research Governance and Development, Gold Coast University HospitalNeonatal Services and Newborn Research, The Royal Women’s HospitalMater Research Institute, Faculty of Medicine, The University of QueenslandMater Research Institute, Faculty of Medicine, The University of QueenslandSchool of Applied Psychology, Griffith UniversityNeonatal Services and Newborn Research, The Royal Women’s HospitalAbstract 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.https://doi.org/10.1186/s13063-023-07224-0Bayley-4Early nutritional learningFollow-upNeurodevelopmentPreterm |
| spellingShingle | Friederike Beker Ian P. Hughes Sue Jacobs Helen G. Liley Samudragupta Bora Gabrielle Simcock Peter G. Davis Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol Trials Bayley-4 Early nutritional learning Follow-up Neurodevelopment Preterm |
| title | Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol |
| title_full | Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol |
| title_fullStr | Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol |
| title_full_unstemmed | Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol |
| title_short | Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol |
| title_sort | smell and taste of milk during tube feeding of preterm infants neurodevelopmental follow up of the randomized taste trial study protocol |
| topic | Bayley-4 Early nutritional learning Follow-up Neurodevelopment Preterm |
| url | https://doi.org/10.1186/s13063-023-07224-0 |
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