High-Calorie Formula for Neonatal Abstinence Syndrome
Recruiting in Palo Alto (17 mi)
Overseen byMatthew Grossman, MD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Must be taking: Methadone
Disqualifiers: Major congenital malformations, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.
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 High-calorie formula for Neonatal Abstinence Syndrome?
Research shows that high-energy formulas can help infants with growth issues gain weight effectively, as seen in cases of growth faltering and critical illnesses. These formulas provide extra calories and nutrients, which can be beneficial for infants needing additional nutrition, like those with Neonatal Abstinence Syndrome.
12345Is high-calorie formula safe for infants?
Research suggests that high-energy infant formulas are generally safe for infants, with studies showing they can be used without major side effects. However, more data is needed to fully understand their long-term safety and effects on growth and metabolism.
12678How is the high-calorie formula treatment different for neonatal abstinence syndrome?
The high-calorie formula is unique because it provides more energy per volume compared to standard formulas, which may help infants with neonatal abstinence syndrome (NAS) who have increased energy needs. This approach is different from other treatments that focus on reducing symptoms or using medications, as it aims to support growth and energy intake directly through nutrition.
128910Eligibility Criteria
This trial is for NAS infants born to mothers aged 18-45 who used methadone during pregnancy. The babies must be at least 36 weeks gestational, over 2200 grams, and not placed for adoption. They should be delivered at Yale New Haven Hospital with plans to attend follow-up visits.Inclusion Criteria
Delivered at: Yale New Haven Hospital
Confirm that mothers are planning to deliver their infant(s) at Yale New Haven Hospital
My baby was born at or after 36 weeks of pregnancy.
+8 more
Exclusion Criteria
My infant was in the NICU for more than a day for reasons other than NAS treatment within their first 3 days.
Newborns with serious birth defects.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Infants are randomly assigned to either high-calorie or standard-calorie formula for 14 days
2 weeks
Daily weight measurements
Follow-up
Participants are monitored for weight gain and return to birthweight after treatment
2 weeks
Daily weight measurements at home
Extended Follow-up
Participants are monitored for days to return to birthweight and overall weight change
1 month
Participant Groups
The study tests if a high-calorie formula can help NAS infants gain weight better than standard formula. Infants are randomly assigned to one of the two feeding regimens while being managed via the Eat, Sleep, Console approach.
2Treatment groups
Experimental Treatment
Active Control
Group I: High-calorie formulaExperimental Treatment1 Intervention
Infant randomly assigned to high-calorie formula for 14 days
Group II: Standard calorie formulaActive Control1 Intervention
Infant randomly assigned to standard-calorie formula for 14 days
High-calorie formula is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as High-calorie formula for:
- Failure to thrive (FTT)
- Low birth weight infants
- Premature infants needing extra calories
🇪🇺 Approved in European Union as High-calorie formula for:
- Preterm infants requiring higher caloric intake
- Infants with feeding difficulties needing extra calories
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale New Haven HospitalNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Should high-energy infant formula be given at full strength from its first day of usage? [2008]To evaluate the feeding tolerance of a high-energy (1 kcal mL(-1)) infant formula (HEIF) for infants with faltering growth, weighing 2.5-8 kg, when administered at full strength from day 1 compared with stepwise introduction.
High-energy nutrition in paediatric cardiac critical care patients: a randomized controlled trial. [2020]Previous studies have shown that feeding a high-energy formula (HF) to infants after cardiac surgery increases energy intake, with fewer side effects on cardiopulmonary function. However, impacts on weight gain and gastrointestinal function remain unclear.
Case Report: Energy- and Nutrient-Dense Formula for Growth Faltering: A Report of Two Cases From India. [2021]Infants hospitalized for critical illnesses are at a high risk of undernutrition because of increased nutrient requirements (due to increased metabolism) and decreased nutrient intake (due to disease-related problems such as anorexia or feeding difficulties). This can result in a slowing down of their normal growth, referred to as "growth faltering." Appropriate nutritional management of these infants is extremely important to avoid long-term adverse outcomes. Administration of energy- and nutrient-dense formula (ENDF; 100 kcal energy and 2.6 g protein per 100 mL, with added micronutrients) can be an effective means of increasing the nutrient and energy intake of these children. Despite the high prevalence of undernutrition and growth faltering among pediatric patients in India, there is a paucity of literature on the use of ENDF in Indian infants. Herein, we report the successful use of ENDF for the nutritional management of two infants hospitalized for growth faltering because of severe upper airway obstruction. The aim of nutritional management was to achieve satisfactory weight gain, which can lead to spontaneous resolution of upper airway obstruction. ENDF was initially administered to provide 50-100 kcal/kg/day, and the dose was gradually increased to 160-185 kcal/kg/day. Both infants tolerated the formula well and showed satisfactory weight gain. These cases clearly demonstrate that early administration of ENDF is an effective means of increasing nutrient and energy intake of critically ill infants, thereby facilitating catchup growth, without any notable adverse effects.
Randomized comparison of a nutrient-dense formula with an energy-supplemented formula for infants with faltering growth. [2008]The practice of supplementing standard infant formula with energy for infants with faltering growth has been widespread. This increases energy density but disturbs the protein : energy ratio, and increases risks of microbial contamination and errors in feed preparation. This study aimed to compare the effectiveness of a nutrient-dense formula (NDF) with an energy-supplemented formula (ESF) in infants with faltering growth.
Human milk fortification and use of infant formulas to support growth in the neonatal intensive care unit. [2023]Newborn infants require adequate nutrition to achieve full potential growth and development. Early life nutrition and health impacts long-term outcomes through adulthood. Human milk is the optimal source of nutrition during the first 6 months of life. However, infants admitted to the neonatal intensive care unit (NICU) often have comorbidities that create more or different nutrition demands than healthy newborns. There are different strategies to meet the nutrition needs of sick newborns, including use of parenteral nutrition, human milk fortifiers (HMFs), and infant formulas. Multinutrient HMFs are frequently used to achieve the higher nutrition demands of preterm infants. They are available in various presentations, such as human milk- or cow milk-derived, liquid or powder, and acidified or nonacidified, each of which has different risks and benefits associated with its use. Infant formulas are available to meet a demand when mother's own milk or donor breast milk is not available or sufficient, and there are also specialty formulas for infants with certain diseases that present unique nutrition needs. This review is focused on the use of HMFs to support the unique nutrition requirements of preterm infants for healthy growth, as well as the indications for the use of formulas among infants in the NICU.
Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus. [2022]Partially hydrolyzed formulas (pHFs) are increasingly used worldwide, both in the prevention of atopic disease in at-risk infants and in the therapeutic management of infants with functional gastrointestinal manifestations. Because prevention is always preferable to treatment, we reviewed the literature aiming to find an answer for the question whether pHF may be recommended for feeding all infants if breast-feeding is not possible. PubMed and Cochrane databases were searched up to December 2014. In addition, to search for data that remained undetected by the searches, we approached authors of relevant articles and major producers of pHFs asking for unpublished data. Because few data were found, nonrandomized, controlled trials and trials in preterm infants were included as well. Overall, only limited data could be found on the efficacy and safety of pHF in healthy term infants. Available data do not indicate that pHFs are potentially harmful for healthy, term infants. With respect to long-term outcomes, particularly referring to immune, metabolic and hormonal effects, data are, however, nonexistent. From a regulatory point of view, pHFs meet the nutrient requirements to be considered as standard formula for term healthy infants. Cost, which is different from country to country, should be considered in the decision-making process. Based on limited available data, the use of pHF in healthy infants is safe with regard to growth. The lack of data, in particular for metabolic consequences and long-term outcomes, is, however, the basis for our recommendation that health authorities should develop and support long-term follow-up studies. Efficacy and long-term safety data are required before a recommendation of this type of formula for all infants can be made.
Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Noninferiority Trial. [2019]A high protein content of nonhydrolyzed infant formula exceeding metabolic requirements can induce rapid weight gain and obesity. Hydrolyzed formula with too low protein (LP) content may result in inadequate growth. The aim of this study was to investigate noninferiority of partial and extensively hydrolyzed formulas (pHF, eHF) with lower hydrolyzed protein content than conventionally, regularly used formulas, with or without synbiotics for normal growth of healthy term infants.
[Clinical effect of extensively hydrolyzed formula in preterm infants: an analysis of 327 cases]. [2020]To investigate the effect and safety of extensively hydrolyzed formula (EHF) in preterm infants.
Effect of Low Lactose Formula on the Short-Term Outcomes of Neonatal Abstinence Syndrome: A Systematic Review. [2021]The use of low lactose formula (LLF) in term and near-term infants in infants with neonatal abstinence syndrome (NAS) has been increasing recently. However, the clinical evidence of such use is limited. Our aim in this paper was to systematically review the current literature about the use of LLF in infants with NAS. We searched PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Database of Systematic Reviews for articles published between 2015 and 2020. Only randomized controlled trials, prospective, and retrospective studies. The risk of bias was assessed by using published tools appropriate for the study type. The certainty of the evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Forty-one titles and/or abstracts were screened independently by 2 reviewers (MA and GA). After an indepth review, 4 studies answered the study question (1 randomized controlled trial (RCT), 2 retrospective studies, and 1 quality improvement study). A meta-analysis could not be completed due to the study type difference and how the outcomes were reported. The studies found no benefit to feeding LLF to infants with NAS regarding short-term outcomes (length of stay, duration, and need for pharmacological therapy and growth). Certainty in the evidence is low. In conclusion we found no beneficial effects regarding the need for pharmacological therapy, duration of pharmacological treatment, length of hospital stay, and growth of using LLF compared to the standard formula in infants with NAS.
Effects of Partially Hydrolyzed Formula on Severity and Outcomes of Neonatal Abstinence Syndrome. [2021]This study compares the effect of partially hydrolyzed formula (PHF) and standard formula (SF) on the severity and short-term outcomes of neonatal abstinence syndrome (NAS).