Dietary Intervention for Feeding Difficulties in Large Infants
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nemours Children's Clinic
Disqualifiers: Respiratory support, Unsafe swallowing, GI surgery, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment Dietary Intervention for Feeding Difficulties in Large Infants?
Research shows that a team approach, including nutritional management, is effective in addressing feeding difficulties in infants by considering various factors like nutrition, medical status, and social situation. Additionally, maternal dietary counseling has been shown to reduce the intake of energy-dense foods in infants, which can be beneficial in managing feeding difficulties.12345
Is dietary intervention for feeding difficulties in large infants safe?
How is the dietary intervention treatment for feeding difficulties in large infants different from other treatments?
Eligibility Criteria
This trial is for large-for-gestational-age (LGA) infants born at or after 35 weeks, who have trouble with oral feeding and a body composition showing excess fat. Infants must not be on respiratory support, have certain swallowing issues, GI surgeries, serious neurological conditions, or major congenital/genetic disorders.Inclusion Criteria
Babies born at 35 weeks or later who have trouble eating and have a high score in body composition measurement will not be included.
Exclusion Criteria
I have had surgery on my digestive system.
My swallowing test shows I have trouble swallowing safely.
I have serious nerve-related health issues.
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Infants are randomized to either FFM-indexed feeding or standard feeding for 2 weeks
2 weeks
2 visits (in-person) for body composition and ARH level assessments
Follow-up
Participants are monitored for clinical and growth outcomes until NICU discharge and through 6 months of age
6 months
4 visits (in-person) at pediatrician's office for well-child visits
Treatment Details
Interventions
- Dietary intervention (Dietary Intervention)
Trial OverviewThe study aims to see if adjusting the diet of LGA infants based on their lean body mass rather than fat can help them eat better. It's testing whether this dietary change improves how much they can take in during feedings.
Participant Groups
2Treatment groups
Active Control
Group I: FFM-indexed feedingActive Control1 Intervention
In FFM-indexed feeding, there will be a permissive feeding volume restriction to 150 ± 10 mL/kg (FFM)/day without increasing the milk calorie density or changing the type of formula milk for 2 weeks in the intervention group
Group II: Standard feedingActive Control1 Intervention
The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory UniversityAtlanta, GA
Cincinnati Children's Hospital Medical CenterCincinnati, OH
Nemours Children's HospitalOrlando, FL
Loading ...
Who Is Running the Clinical Trial?
Nemours Children's ClinicLead Sponsor
Emory UniversityCollaborator
Children's Hospital Medical Center, CincinnatiCollaborator
References
Team management of failure to thrive. [2009]A multidisciplinary team approach to treatment of failure to thrive in infancy and early childhood permits the simultaneous consideration of nutritional, medical, and psychosocial risk factors associated with this complex syndrome. The registered dietitian works with the physician, nurse, and social worker to provide an integrated evaluation of nutrition history, feeding patterns, medical status, social situation, developmental level, and interactional qualities of the child with failure to thrive. Nutritional management of failure to thrive emphasizes: (a) ongoing assessment of nutritional status and rate of catch-up growth, including regular collection of anthropometric measurements; (b) provision of energy and protein in amounts sufficient to meet requirements for catch-up growth; and (c) concrete, individualized nutrition instruction. Long-term follow-up at regular intervals in coordination with other members of the failure-to-thrive team provides the opportunity to reinforce nutrition instruction and to reassess and adapt meal plans to meet the growing child's changing nutritional needs.
Patient-Reported Outcome Measures That Describe the Feeding Skills Domain for Pediatric Feeding Disorder: A Clinimetric Review. [2023]Pediatric feeding disorder (PFD) is defined as "impaired oral intake that is not age-appropriate, and is associated with medical, nutritional, feeding skill, and/or psychosocial dysfunction." Patient-reported outcome measures (PROMs) are tools that complement clinical assessment, but many have limited clinimetric data. This review aimed to assess PROMs that reported on the feeding skills domain for PFD in children.
Efficacy of F-100, diluted F-100, and infant formula as rehabilitation diet for infants aged [2021]To assess the efficacy and safety of F-100, diluted F-100 (F100D), and infant formula (IF) for dietary management in the rehabilitation phase of severe acute malnutrition (SAM) of infants aged under 6 months (u6m).
Maternal dietary counseling reduces consumption of energy-dense foods among infants: a randomized controlled trial. [2016]To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants.
Toward Better Understanding of Pediatric Feeding Disorder: A Proposed Framework for Patient Characterization. [2023]To establish a foundation for methodologically sound research on the epidemiology, assessment, and treatment of pediatric feeding disorder (PFD), a 28-member multidisciplinary panel with equal representation from medicine, nutrition, feeding skill, and psychology from seven national feeding programs convened to develop a case report form (CRF). This process relied upon recent advances in defining PFD, a review of the extant literature, expert consensus regarding best practices, and review of current patient characterization templates at participating institutions. The resultant PFD CRF involves patient characterization in four domains (ie, medical, nutrition, feeding skill, and psychosocial) and identifies the primary features of a feeding disorder based on PFD diagnostic criteria. A corresponding protocol provides guidance for completing the assessment process across the four domains. The PFD CRF promotes a standard procedure to support patient characterization, enhance methodological rigor, and provide a useful clinical tool for providers and researchers working with these disorders.
Modifications to Infant Formula Instructions Improve the Accuracy of Formula Dispensing. [2021]Readability of infant formula preparation instructions is universally poor, which may result in inaccurate infant feeding. Given that inaccurate formula dispensing can lead to altered infant growth and increased adiposity, there is an increased need for easy to follow instructions for formula preparation. We hypothesize that altering infant formula instruction labels using feedback from iterative focus groups will improve the preparation accuracy of powdered infant formula in a randomized controlled trial. Participants were recruited from the community, 18 years of age or older, willing to disclose demographic information for focus group matching, and willing to participate freely in the first (n = 21) or second (n = 150) phase of the study. In the second phase, participants were randomized to use the standard manufacturer instructions or to use the modified instructions created in the first phase. Accuracy was defined as the percent error between manufacturer-intended powder formula quantity and the amount dispensed by the participant. Participants who were assigned to the modified instructions were able to dispense the powdered formula more accurately than participants who used the standard manufacturer instructions (-0.67 ± 0.76 vs. -4.66 ± 0.74% error; p < 0.0001). Accuracy in powdered formula dispensing was influenced by bottle size (p = 0.02) but not by body mass index (p = 0.17), education level (p = 0.75), income (p = 0.7), age (p = 0.89) or caregiver status (p = 0.18). Percent error of water measurement was not different between the groups (standard: -1.4 ± 0.6 vs. modified: 0.7 ± 0.6%; p = 0.38). Thus, caloric density was more accurate in the modified instructions group compared to the standard manufacturer instructions group (-0.3 ± 0.6 vs.-2.9 ± 0.9%; p = 0.03). Infant formula label modifications using focus group feedback increased infant formula preparation accuracy.
Measuring the effects of nutritional counseling on total infant diet in a randomized controlled intervention trial. [2008]To examine the effects of nutritional counseling for the infant diet focused on complementary feeding and total diet by use of dietary scores.
Results from the Strong Families Start at Home/Familias Fuertes Comienzan en Casa: feasibility randomised control trial to improve the diet quality of low-income, predominantly Hispanic/Latinx children. [2023]To describe the feasibility, acceptability and results of Strong Families Start at Home, a 6-month pilot trial of a home-based food parenting/nutrition intervention.
Dietary guidelines for children under 2 years of age in the context of nurturing care. [2020]Dietary guidelines provide advice on what to eat to different subsets of the population but often do not take into account the "how" to eat. Responsive feeding is a key dimension of responsive parenting involving reciprocity between the child and caregiver during the feeding process and is characterized by caregiver guidance and recognition of the child's cues of hunger and satiety. Evidence indicates that providing responsive feeding guidance to mothers on how to recognize and respond appropriately to children's hunger and satiety cues can lead to improved feeding practices and weight status and developmental outcomes among infants and young children. In addition, early and nurturing exposures to foods with different tastes and textures and positive role modelling help children to learn to eat healthy foods. The importance of improving caregiver's responsive feeding behaviours to ensure the adequate introduction of complementary foods is becoming increasing recognized, but responsive feeding principles have not been taken into account in a comprehensive way in the development of dietary guidelines. The incorporation of all responsive feeding principles into dietary guidelines has a strong potential to enhance their impact on early childhood development outcomes for infants and young children but will require adaptation to the different contexts across countries to ensure that they are culturally sensitive and grounded in a deep understanding of the types of foods and other resources available to diverse communities.
How to approach feeding difficulties in young children. [2020]Feeding is an interaction between a child and caregiver, and feeding difficulty is an umbrella term encompassing all feeding problems, regardless of etiology, severity, or consequences, while feeding disorder refers to an inability or refusal to eat sufficient quantities or variety of food to maintain adequate nutritional status, leading to substantial consequences, including malnutrition, impaired growth, and possible neurocognitive dysfunction. There are 6 representative feeding disorder subtypes in young children: infantile anorexia, sensory food aversion, reciprocity, posttraumatic type, state regulation, and feeding disorders associated with concurrent medical conditions. Most feeding difficulties are nonorganic and without any underlying medical condition, but organic causes should also be excluded from the beginning, through thorough history taking and physical examination, based on red-flag symptoms and signs. Age-appropriate feeding principles may support effective treatment of feeding difficulties in practice, and systematic approaches for feeding difficulties in young children, based on each subtype, may be beneficial.
Barriers and enablers to caregivers' responsive feeding behaviour: A systematic review to inform childhood obesity prevention. [2021]Responsive infant feeding is a critical component of childhood obesity prevention. However, there is little guidance for caregivers on how to do this successfully. The first step to developing an intervention to promote responsive feeding is to systematically identify its barriers and enablers. Searches were conducted in CINAHL, Cochrane Library, Medline, Embase, PubMed, PsycINFO, Maternity, and Infant Care from inception to November 2020. All study designs were included if they reported a barrier or enabler to responsive feeding during the first 2 years of life. We used a "best fit" framework synthesis, with the Capacity, Opportunity, Motivation, and Behaviour (COM-B) model. The Mixed Method Appraisal Tool (MMAT) was used to assess study quality. Forty-three studies were included in the review. Barriers (n = 36) and enablers (n = 21) were identified across five COM-B domains: psychological capacity, physical and social opportunity, and reflective and automatic motivation. Enablers were recognition of infant feeding cues, feeding knowledge and family and friends. Caregiver attitude toward control of feeding was a barrier, together with health care professional advice about formula feeding and breastfeeding expectation. These barriers and enablers provide a comprehensive evidence base to guide intervention development to improve responsive feeding and prevent obesity across individual and population levels.
Body adiposity and oral feeding outcomes in infants: a pilot study. [2021]Prevalence of oral feeding difficulties in high-risk infants is increasing. Desire to take orally can be influenced by hunger and satiety, which may influence growth and body fat.
RAISE (Raising Infants to Be Smart Eaters) Pilot Study. [2023]Background: Many of the complex determinants of obesity originate during infancy when small changes in the environment can permanently influence appetite, behavior, and energy metabolism. Parent feeding style ("how" rather than "what" to feed) has emerged as a potentially important factor in early obesity prevention. Objectives: (1) To assess the feasibility of conducting a brief responsive feeding education intervention by public health nurses during routine well-baby visits. (2) To assess whether this intervention affects parents' attitudes and behavior related to responsive feeding. Methods: Prospective, nonrandomized, comparative pilot study conducted in two communities. Intervention participants were exposed to enhanced responsive feeding education by public health nurses at routine well-baby visits from 0 to 18 months along with wall posters, handouts, automated text messages and tangible takeaways. Parent knowledge and behavior were measured using the Infant Feeding Style Questionnaire and the Toddler Development Index. Feasibility and acceptability were assessed by patients and nurses through open text feedback forms and mid-point and exit interviews. Results: Recruitment (18 intervention; 9 control) and retention fell below targets. Average adherence to protocol by nurses from 0 to 12 months was 89%. Delivery of the intervention was feasible and acceptable, but the additional research-related tasks were challenging in a busy clinical setting. Parents found the different formats and information new and helpful. There was a trend toward less nonresponsive (pressuring, restrictive, laissez-faire) feeding practices in the intervention group. Conclusions: This pilot study demonstrated encouraging results related to overall feasibility and effect on parent feeding style.
Feeding disorders in children: taking an interdisciplinary approach. [2019]Feeding problems are common in children with special healthcare needs, and inquiring about feeding skills should be a routine part of the developmental assessment. Failure to meet normal feeding milestones, the presence of swallowing problems, and the presence or history of placement of a nasogastric or gastrostomy tube are all reasons to refer a child for a feeding evaluation. An interdisciplinary approach that includes the pediatrician along with a feeding team that includes a speech pathologist, occupational therapist, feeding-oriented nutritionist, and often others, should be taken to diagnose and manage feeding disorders in such children as early as possible for the best prognosis. However, caregivers also play a critical role in intervention, and effective management of feeding disorders should always be seen as a partnership between the caregiver and the interdisciplinary team. The additional benefit is the feeling of competence by the caregiver who is properly trained in the feeding of his/her special needs child. Providing caregivers with proper training as well as realistic goals, regular instruction for home practice, and the expectation for periodic setbacks, can help the child and the caregiver reap the most benefit from feeding intervention.