Dietary Intervention for Feeding Difficulties in Large Infants

Recruiting at 2 trial locations

Overseen By Sreekanth Viswanathan, MD,MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Respiratory support, Unsafe swallowing, GI surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special feeding plan to help large babies who have trouble eating by mouth. It examines whether a diet based on fat-free mass (the part of the body that isn't fat) can improve the amount these infants can eat. Participants are divided into two groups: one follows this specific diet, while the other continues with regular feeding. This trial may suit large babies born at 35 weeks or later who struggle to eat by mouth and have higher body fat levels. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance feeding strategies for infants.

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 prior data suggests that this dietary intervention is safe for large infants?

Research has shown that changing an infant's diet can be safe, though evidence remains limited. Studies on similar changes in infants are rare, but available information has not revealed major safety problems.

Typically, these dietary changes for infants are gentle and closely monitored. They often involve adjusting the quantity of food rather than the type, making them generally manageable for infants.

In the trial under consideration, the diet changes last only two weeks, which helps reduce the risk of side effects.

In summary, although few studies exist on this specific change, similar dietary adjustments have not shown significant safety issues. This approach is usually considered safe and is closely monitored to maintain infant health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel dietary approach to address feeding difficulties in large infants. Unlike standard feeding methods that aim for a fixed oral feeding volume, the FFM-indexed feeding introduces a permissive feeding volume restriction based on fat-free mass (FFM). This approach could potentially optimize growth and nutritional intake without changing the calorie density or formula type, offering a more tailored and potentially effective solution for managing feeding challenges in this population.

What evidence suggests that this dietary intervention could be effective for feeding difficulties in large infants?

Studies have shown that babies larger than average at birth often have more body fat due to receiving extra energy before birth. This extra body fat can hinder their ability to learn proper feeding. In this trial, one group of participants will receive FFM-indexed feeding, which adjusts feeding based on fat-free mass (including everything in the body except fat, like muscles and bones). This method controls intake without altering the type of milk or its calorie content. Early evidence is promising, indicating that focusing on fat-free mass can improve feeding outcomes for these babies. Another group will follow a standard feeding approach. ^{6 7 8 9 10}

Who Is on the Research Team?

Sreekanth Viswanathan, MD

Principal Investigator

Nemours Children's Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dietary intervention

Trial Overview The 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.

How Is the Trial Designed?

Group I: FFM-indexed feeding Active Control 1 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 feeding Active Control 1 Intervention

The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

Modifying infant formula preparation instructions based on feedback from focus groups significantly improved the accuracy of formula dispensing, with participants using modified instructions making less error (-0.67% vs. -4.66% error) compared to those using standard instructions.

The study involved 171 participants, and while bottle size influenced accuracy, factors like education level and caregiver status did not, highlighting the importance of clear instructions for all users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifications to Infant Formula Instructions Improve the Accuracy of Formula Dispensing. Gilmore, LA., Altazan, AD., Flanagan, EW., et al.[2021]

Feeding difficulties in children can lead to serious issues like malnutrition and impaired growth, and they can be categorized into six subtypes, including infantile anorexia and sensory food aversion.

Most feeding difficulties are nonorganic, meaning they don't stem from medical conditions, but it's crucial to rule out any organic causes through careful assessment before implementing age-appropriate treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to approach feeding difficulties in young children. Yang, HR.[2020]

A pilot study involving 27 parents (18 in the intervention group and 9 in the control group) showed that a brief responsive feeding education intervention by public health nurses during well-baby visits is feasible and acceptable, despite challenges in recruitment and retention.

Parents who received the intervention exhibited a trend towards adopting less nonresponsive feeding practices, suggesting that the education may positively influence their attitudes and behaviors related to feeding their infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RAISE (Raising Infants to Be Smart Eaters) Pilot Study. Hale, I., Fergus, T., Buhler, H., et al.[2023]

A randomized controlled trial involving 397 low-income mothers and infants in Brazil showed that dietary counseling significantly reduced the intake of energy-dense foods, with a 40% reduction in lipid-dense foods and a 50% reduction in sugar-dense foods among infants.

Exclusive breastfeeding for up to 6 months was associated with a substantial decrease in the risk of consuming energy-dense foods, reducing the likelihood of lipid-dense and sugar-dense food consumption by 58% and 67%, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal dietary counseling reduces consumption of energy-dense foods among infants: a randomized controlled trial. Vitolo, MR., Bortolini, GA., Campagnolo, PD., et al.[2016]

In a study involving 183 mothers of full-term infants, personalized telephone counseling significantly improved the infants' diets, making them closer to dietary recommendations compared to those who received less or no counseling.

The results suggest that direct communication, such as telephone counseling, is more effective than written information in guiding mothers on complementary feeding and overall infant nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the effects of nutritional counseling on total infant diet in a randomized controlled intervention trial. Koehler, S., Sichert-Hellert, W., Kersting, M.[2008]

In a study of 32 infants (16 on tube feeding and 16 on full oral feeding), those on tube feeding had significantly lower oral intake (66 ml/kg/day) compared to those feeding orally (168 ml/kg/day), indicating that feeding method impacts oral intake.

Infants on tube feeding also had higher body fat percentages (18.7% vs. 10.9%) and fat mass z-scores, suggesting that increased body adiposity may negatively affect oral feeding outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body adiposity and oral feeding outcomes in infants: a pilot study. Viswanathan, S., Osborn, E., Jadcherla, S.[2021]

A multidisciplinary team approach is essential for effectively treating failure to thrive in infants and young children, as it allows for a comprehensive evaluation of nutritional, medical, and psychosocial factors.

Nutritional management focuses on continuous assessment of growth, ensuring adequate energy and protein intake for catch-up growth, and providing personalized nutrition guidance, with long-term follow-up to adapt plans as the child grows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team management of failure to thrive. Peterson, KE., Washington, J., Rathbun, JM.[2009]

A review of 14 patient-reported outcome measures (PROMs) for pediatric feeding disorder (PFD) highlighted that many tools focus on feeding skills but vary in methodological quality, with newer tools generally showing better validity.

It is recommended to use PROMs that include measures of social participation and have strong content validity to enhance assessments for PFD, emphasizing the importance of considering both caregiver and child perspectives in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures That Describe the Feeding Skills Domain for Pediatric Feeding Disorder: A Clinimetric Review. Marshall, J., Gosa, MM., Dodrill, P.[2023]

In a study involving 153 infants under 6 months with severe acute malnutrition, those fed F-100 and diluted F-100 (F-100D) experienced significantly greater weight gain compared to those receiving infant formula, indicating F-100's superior efficacy in rehabilitation.

F-100 was found to be safe for use, as it did not elevate serum sodium levels and maintained normal urinary specific gravity, suggesting it can be used without the need for alternative formulations during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of F-100, diluted F-100, and infant formula as rehabilitation diet for infants aged Islam, MM., Huq, S., Hossain, MI., et al.[2021]

A multidisciplinary panel developed a comprehensive case report form (CRF) for pediatric feeding disorder (PFD) that includes assessments across medical, nutritional, feeding skill, and psychosocial domains, enhancing the understanding and treatment of PFD.

The CRF aims to standardize patient characterization and improve research methodology, providing a valuable tool for clinicians and researchers to better assess and treat children with feeding disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Better Understanding of Pediatric Feeding Disorder: A Proposed Framework for Patient Characterization. Sharp, WG., Silverman, A., Arvedson, JC., et al.[2023]

The Strong Families Start at Home pilot trial demonstrated feasibility and high acceptability, with 63% of participating families retained over 6 months, despite challenges posed by COVID-19.

The intervention led to significant improvements in healthy eating behaviors, including increased consumption of whole fruits and reduced sodium intake, along with enhanced food parenting practices such as regular meal timing and minimizing distractions during meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Tovar, A., Fox, K., Gans, KM., et al.[2023]

Responsive feeding, which involves caregivers recognizing and responding to children's hunger and satiety cues, can significantly improve feeding practices and developmental outcomes in infants and young children.

Incorporating responsive feeding principles into dietary guidelines has the potential to enhance early childhood development, but these guidelines need to be culturally sensitive and adapted to the specific food resources available in different communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary guidelines for children under 2 years of age in the context of nurturing care. Pérez-Escamilla, R., Segura-Pérez, S., Hall Moran, V.[2020]

A systematic review of 43 studies identified key barriers and enablers to responsive infant feeding, which is important for preventing childhood obesity, using the COM-B model to categorize findings.

Enablers included recognizing infant feeding cues and having supportive family and friends, while barriers involved caregiver attitudes towards feeding control and conflicting advice from healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and enablers to caregivers' responsive feeding behaviour: A systematic review to inform childhood obesity prevention. Redsell, SA., Slater, V., Rose, J., et al.[2021]

Children with special healthcare needs often experience feeding problems, making it essential to assess their feeding skills during developmental evaluations and refer them for feeding evaluations when necessary.

An interdisciplinary approach involving various specialists, along with active caregiver participation and training, is crucial for effectively managing feeding disorders and improving outcomes for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding disorders in children: taking an interdisciplinary approach. Ayoob, KT., Barresi, I.[2019]

Citations

1. withpower.com withpower.com/trial/phase-fetal-macrosomia-8-2021-f08a4

Dietary Intervention for Feeding Difficulties in Large Infants 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 ...

2. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Nutrition%20Disorder%2C%20Infant%22

San Mateo Clinical Trials 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25940825/

Prediction of Fat-Free Mass in Children A maturation model was developed to predict FFM in children, using a dataset of 496 females and 515 males, and performed well in both.

4. researchgate.net researchgate.net/publication/286132700_PO-0459_Fat_Massfm_And_Fat_Free_Massffm_Indices_In_Preterm_And_Term_Infants_During_First_6_Months_Of_Life

(PDF) PO-0459 Fat Mass(fm) And Fat Free Mass(ffm) ... We present longitudinal data from a large dataset of stable growing infants. Methods BC data (n = 857) from 574 infants (22–42 wks) enrolled ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Feeding%3B%20Difficult%2C%20Newborn%22

San Mateo Clinical Trials 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 ...

6. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)12921-2/fulltext

Nutrition in infancy and long-term risk of obesity The change in z score for length between randomization and the end of the dietary intervention at age 9 was also associated with later adiposity in study 1 but ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2695671

Effect of a Responsive Parenting Educational Intervention ... A responsive parenting intervention significantly reduced body mass index z scores compared with controls (−0.13 vs 0.15, respectively) at age 3 years.

8. researchgate.net researchgate.net/publication/237097421_Outcomes_of_an_Early_Feeding_Practices_Intervention_to_Prevent_Childhood_Obesity

Outcomes of an Early Feeding Practices Intervention to ... Results: Retention at follow-up was 78%. Mothers in the intervention group reported using responsive feeding more frequently on 6 of 9 subscales ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8107859/

Effectiveness of dietary interventions on weight outcomes ... In our study, individuals who received dietary intervention had greater reduction in BMI z-score. However, 5 of the included studies showed contrast conclusions ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1744165X25000307

Short- and longer-term growth and development of fat ... Intervention studies using body composition measurements to guide NICU-based interventions are lacking; and the relative utility of fat-free mass compared to ...