Review of Infant Oral Feeding and Skills

NCT06736743 | Enrolling By Invitation

• 2 other identifiers: IRB00120659AR00057
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral feeding.

Conditions

Nutrition Disorders; Gastrointestinal Disease; Deglutition Disorder; Feeding Difficulties; Swallowing Difficulties; Infant, Newborn; Infant, Premature, Nutrition; Pediatric Feeding Disorder, Chronic; Retrospective Studies; Breastfeeding; Mental Health Wellness; Intensive Care Units, Neonatal; Bottle Feeding; Humans; Cohort Studies

Keywords

nutrition; infant; neonate; dysphagia; synactive theory of development; life course health development; feeding skill assessment (FSA); SMART Tool; deglutition

Outcome Measures

Primary Outcomes (1)

• Capable Feeding Skills at Discharge

  Based on the Last Feeding Skill Assessment (FSA) Score, calculate the percentage of infants in the "capable" range/ total included infants. The SMART tool evaluates feeding skills across five domains: State of arousal, motor tone, autonomic instability, response to stimulation, and total oral skills. The score has a minimum value of 25 and a maximum value of 100; higher scores mean a better outcome. The post-feed SMART Tool score classifies the infant feeding skills into three categories: caution (25 to 60), developing (60 to 90), and capable (91 to 100).

  At discontinuation of SMART Tool Scoring for up to 6 months.

Secondary Outcomes (1)

• Feeding Skills Distribution at Discharge.

  At discontinuation of SMART Tool Scoring for up to 6 months.

Other Outcomes (4)

• Last FSA Score at discontinuation of SMART Tool scoring.

  At discontinuation of SMART Tool Scoring for up to 6 months.

• Length of Stay

  Duration of hospitalization in days, for up to 6 months.

• Time from Start oral feeds to Full oral feeds

  From start of oral feeds to removal of Nasogastric tubes in days, for up to 6 months.

Study Arms (1)

NICU Infants

One cohort of infants who were admitted and discharged during the study period.

Diagnostic Test: SMART Tool for Feeding Skill Assessment

Interventions

SMART Tool for Feeding Skill Assessment DIAGNOSTIC_TEST

Infant Oral Feeding Skill Assessment (FSA) done using SMART Tool

NICU Infants

Eligibility Criteria

• Age: 22 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates admitted and discharged from Advocate Illinois Masonic Medical Center (AIMMC) Neonatal Intensive Care Unit (NICU)

You may qualify if:

• Neonates admitted and discharged from Advocate Illinois Masonic Medical Center (AIMMC) Neonatal Intensive Care Unit (NICU) from April 1, 2024 to September 30, 2024

You may not qualify if:

• Discharged without attaining full independent oral feeds by volume. This excludes infant deaths and transfers without attaining full oral feeds.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

Related Publications (11)

• Sanders MR, Hall SL. Trauma-informed care in the newborn intensive care unit: promoting safety, security and connectedness. J Perinatol. 2018 Jan;38(1):3-10. doi: 10.1038/jp.2017.124. Epub 2017 Aug 17.

  PMID: 28817114 BACKGROUND

• Russ SA, Hotez E, Berghaus M, Verbiest S, Hoover C, Schor EL, Halfon N. What Makes an Intervention a Life Course Intervention? Pediatrics. 2022 May 1;149(Suppl 5):e2021053509D. doi: 10.1542/peds.2021-053509D.

  PMID: 35503318 BACKGROUND

• Pineda R, Prince D, Reynolds J, Grabill M, Smith J. Preterm infant feeding performance at term equivalent age differs from that of full-term infants. J Perinatol. 2020 Apr;40(4):646-654. doi: 10.1038/s41372-020-0616-2. Epub 2020 Feb 17.

  PMID: 32066844 BACKGROUND

• Goday PS, Huh SY, Silverman A, Lukens CT, Dodrill P, Cohen SS, Delaney AL, Feuling MB, Noel RJ, Gisel E, Kenzer A, Kessler DB, Kraus de Camargo O, Browne J, Phalen JA. Pediatric Feeding Disorder: Consensus Definition and Conceptual Framework. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):124-129. doi: 10.1097/MPG.0000000000002188.

  PMID: 30358739 BACKGROUND

• Browne JV, Jaeger CB, Kenner C; Gravens Consensus Committee on Infant and Family Centered Developmental Care. Executive summary: standards, competencies, and recommended best practices for infant- and family-centered developmental care in the intensive care unit. J Perinatol. 2020 Sep;40(Suppl 1):5-10. doi: 10.1038/s41372-020-0767-1.

  PMID: 32859958 BACKGROUND

• American Academy of Pediatrics Committee on Fetus and Newborn. Hospital discharge of the high-risk neonate. Pediatrics. 2008 Nov;122(5):1119-26. doi: 10.1542/peds.2008-2174.

  PMID: 18977994 BACKGROUND

• Alshaikh B, Yusuf K, Dressler-Mund D, Mehrem AA, Augustine S, Bodani J, Yoon E, Shah P; Canadian Neonatal Network (CNN) and Canadian Preterm Birth Network (CPTBN) Investigators. Rates and Determinants of Home Nasogastric Tube Feeding in Infants Born Very Preterm. J Pediatr. 2022 Jul;246:26-33.e2. doi: 10.1016/j.jpeds.2022.03.012. Epub 2022 Mar 14.

  PMID: 35301017 BACKGROUND

• Milette I, Martel MJ, Ribeiro da Silva M, Coughlin McNeil M. Guidelines for the Institutional Implementation of Developmental Neuroprotective Care in the Neonatal Intensive Care Unit. Part A: Background and Rationale. A Joint Position Statement From the CANN, CAPWHN, NANN, and COINN. Can J Nurs Res. 2017 Jun;49(2):46-62. doi: 10.1177/0844562117706882.

  PMID: 28841058 BACKGROUND

• Edwards L, Cotten CM, Smith PB, Goldberg R, Saha S, Das A, Laptook AR, Stoll BJ, Bell EF, Carlo WA, D'Angio CT, DeMauro SB, Sanchez PJ, Shankaran S, Van Meurs KP, Vohr BR, Walsh MC, Malcolm WF; Eunice Kennedy Shriver National Institute of Child Health and Human Development. Inadequate oral feeding as a barrier to discharge in moderately preterm infants. J Perinatol. 2019 Sep;39(9):1219-1228. doi: 10.1038/s41372-019-0422-x. Epub 2019 Jul 11.

  PMID: 31296918 BACKGROUND

• Lubbe W. Clinicians guide for cue-based transition to oral feeding in preterm infants: An easy-to-use clinical guide. J Eval Clin Pract. 2018 Feb;24(1):80-88. doi: 10.1111/jep.12721. Epub 2017 Mar 2.

  PMID: 28251754 BACKGROUND

• Pados BF, Hill RR, Yamasaki JT, Litt JS, Lee CS. Prevalence of problematic feeding in young children born prematurely: a meta-analysis. BMC Pediatr. 2021 Mar 6;21(1):110. doi: 10.1186/s12887-021-02574-7.

  PMID: 33676453 BACKGROUND

MeSH Terms

Conditions

Nutrition Disorders; Gastrointestinal Diseases; Deglutition Disorders; Premature Birth; Bronchiolitis Obliterans Syndrome; Breast Feeding; Bottle Feeding

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Digestive System Diseases; Esophageal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Feeding Behavior; Behavior

Study Officials

• Ravi Mishra, MD, FAAP

  Advocate Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 17, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)