Dataset Information

Early high-energy feeding in infants following cardiac surgery: a randomized controlled trial.

ABSTRACT:

Background

Effective nutrition programs are beneficial for nutritional recovery in infants. Few studies have focused on the effect of early high-energy feeding after open heart surgery. This study sought to assess the effects of early high-energy feeding in infants after congenital heart surgery.

Methods

Patients at a tertiary pediatric cardiology center who underwent open heart surgery between July 2016 and July 2018 were recruited and randomly allocated to 1 of the following 2 groups: (I) the intervention group (postoperative early high-energy feeding; n=124); and (II) the control group (no intervention; n=120).The primary endpoints of average energy delivery and growth Z-scores [i.e., weight-for-height Z-score (WHZ), weight-for-age Z-score (WAZ), and height-for-age Z-score (HAZ)] were recorded preoperatively, during the intensive care unit (ICU) stay, at discharge, and at 1 and 3 months postoperatively. The secondary endpoints of malnutrition recovery, ventilator support time, infection rate, and cardiac ICU (CICU) stay were also recorded.

Results

A total of 244 infants were included in the study. There were no significant differences in the baseline features between the 2 groups. The intervention group received higher calories on average than the control group (44.5 vs. 34.7; P<0.001). At discharge from the ICU, the WHZ (-2.29 vs. -2.76; P<0.001) and WAZ (-3.08 vs. -3.43; P=0.005) of patients in the intervention group were higher than those of patients in the control group. Ventilator support time (P=0.004), CICU stay (P=0.045), and infection rate (P=0.001) were significantly lower in the intervention group than the control group. At 3 months post-surgery, the intervention group exhibited a higher malnutrition recovery rate than the control group (19.4% vs. 6.5%; P=0.002).

Conclusions

The administration of early high-energy feeding to infants after congenital heart surgery is associated with improved growth, reduced CICU stay, decreased ventilator support time, and reduced postoperative infection rates.

Trial registration

ClinicalTrials NCT04609358.

SUBMITTER: Chen X

PROVIDER: S-EPMC8578776 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

Early high-energy feeding in infants following cardiac surgery: a randomized controlled trial.

Chen Xi X Zhang Mingjie M Song Yixiao Y Luo Yiwen Y Wang Liping L Xu Zhuoming Z Bao Nan N

Translational pediatrics 20211001 10

<h4>Background</h4>Effective nutrition programs are beneficial for nutritional recovery in infants. Few studies have focused on the effect of early high-energy feeding after open heart surgery. This study sought to assess the effects of early high-energy feeding in infants after congenital heart surgery.<h4>Methods</h4>Patients at a tertiary pediatric cardiology center who underwent open heart surgery between July 2016 and July 2018 were recruited and randomly allocated to 1 of the following 2 g ...[more]

PMID: 34765467

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Project description:BackgroundDue to insufficient evidence, extremely preterm infants (≤28 wk of gestation) rarely receive early progressive feeding (small increments of feeding volumes between 1 and 4 d after birth). We hypothesized that early progressive feeding increases the number of full enteral feeding days in the first month after birth.ObjectiveThe aim of this study was to determine the feasibility and efficacy of early progressive feeding in extremely preterm infants.DesignIn this single-center randomized trial, extremely preterm infants born between September 2016 and June 2017 were randomly assigned to receive either early progressive feeding without trophic feeding (early feeding group) or delayed progressive feeding after a 4-d course of trophic feeding (delayed feeding group). Treatment allocation occurred before or on feeding day 1. The primary outcome was the number of full enteral feeding days in the first month after birth. Secondary outcomes were death, necrotizing enterocolitis (NEC), culture-proven sepsis, growth percentiles at 36 wk postmenstrual age, use of parenteral nutrition, and need for central venous access.ResultsSixty infants were included (median gestational age: 26 wk; mean ± SD birth weight: 832 ± 253 g). The primary outcome differed between groups (median difference favoring the early feeding group: +2 d; 95% CI: 0, 3 d; P = 0.02). Early progressive feeding reduced the use of parenteral nutrition (4 compared with 8 d; P ≤ 0.01) and the need for central venous access (9 compared with 13 d; P ≤ 0.01). The outcome of culture-proven sepsis (10% compared with 27%; P = 0.18), restricted growth (weight, length, and head circumference <10th percentile) at 36 wk postmenstrual age (25% compared with 50%; P = 0.07), and the composite outcome of NEC or death (27% compared with 20%; P = 0.74) did not differ between groups.ConclusionEarly progressive feeding increases the number of full enteral feeding days in extremely preterm infants. This trial was registered at www.clinicaltrials.gov as NCT02915549.

Project description:BackgroundTo prevent postoperative complications, delayed oral feeding (DOF) remains a common model of care following pediatric intestinal anastomosis surgery; however, early oral feeding (EOF) has been shown to be safe and effective in reducing the incidence of complications and fast recovery after pediatric surgery. Unfortunately, the evidence in support of EOF after intestinal anastomosis (IA) in infants is insufficient. Therefore, this study was primarily designed to evaluate the safety and efficacy of EOF. In addition, the current status of EOF application and associated factors that favor or deter EOF implementation were also assessed.MethodsA total of 898 infants were divided into two groups (EOF group, n = 182; DOF group, n = 716), and the clinical characteristics were collected to identify the factors associated with EOF in infants. Complications and recovery were also compared to define the safety and efficacy after balancing the baseline data by propensity score matching (PSM) (EOF group, n = 179; DOF group, n = 319).ResultsThe total EOF rate in infants with IA was 20.3%. Multivariate logistic regression revealed significant differences in the EOF rates based on IA site and weight at the time of surgery (OR = 0.652, 95% CI: 0.542-0.784, p < 0.001) and (OR = 1.188, 95% CI: 1.036-1.362, p = 0.013), respectively. The duration of total parenteral nutrition (TPN), parenteral nutrition (PN), and postoperative hospital stay were significantly shorter in the EOF group than the DOF group [2.0 (1.0, 2.0) d vs. 5.0 (3.0, 6.0) d; 6.0 (5.0, 8.0) d vs. 8.0 (6.0, 11.0) d; 10.0 (7.0, 14.0) d vs. 12.0 (9.0, 15.0) d, all p < 0.001]. The rates of abdominal distension and vomiting in the EOF group were significantly higher than the DOF group (17.9% vs. 7.2%, p < 0.001; 7.8% vs. 2.5%, p = 0.006); however, no differences were found in failure to initial OF, diarrhea, hematochezia, and anastomotic leakage between the two groups (p > 0.05).ConclusionThe overall rate of EOF in infants following IA was low, and the sites of anastomosis and weight at surgery were two factors associated with EOF. Nevertheless, performing EOF in infants after IA was safe and effective, reduced PN usage, shortened the hospital stay, and did not increase the rate of severe complications.Clinical Trial Registration: ClinicalTrails.gov, identifier NCT04464057.

Project description:BackgroundAlthough perioperative prophylactic glucocorticoids have been used for decades, whether they improve outcomes in infants after heart surgery with cardiopulmonary bypass is unknown.MethodsWe conducted a multicenter, prospective, randomized, placebo-controlled, registry-based trial involving infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass at 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database. Registry data were used in the evaluation of outcomes. The infants were randomly assigned to receive prophylactic methylprednisolone (30 mg per kilogram of body weight) or placebo, which was administered into the cardiopulmonary-bypass pump-priming fluid. The primary end point was a ranked composite of death, heart transplantation, or any of 13 major complications. Patients without any of these events were assigned a ranked outcome based on postoperative length of stay. In the primary analysis, the ranked outcomes were compared between the trial groups with the use of odds ratios adjusted for prespecified risk factors. Secondary analyses included an unadjusted odds ratio, a win ratio, and safety outcomes.ResultsA total of 1263 infants underwent randomization, of whom 1200 received either methylprednisolone (599 infants) or placebo (601 infants). The likelihood of a worse outcome did not differ significantly between the methylprednisolone group and the placebo group (adjusted odds ratio, 0.86; 95% confidence interval [CI], 0.71 to 1.05; P = 0.14). Secondary analyses (unadjusted for risk factors) showed an odds ratio for a worse outcome of 0.82 (95% CI, 0.67 to 1.00) and a win ratio of 1.15 (95% CI, 1.00 to 1.32) in the methylprednisolone group as compared with the placebo group, findings suggestive of a benefit with methylprednisolone; however, patients in the methylprednisolone group were more likely than those in the placebo group to receive postoperative insulin for hyperglycemia (19.0% vs. 6.7%, P<0.001).ConclusionsAmong infants undergoing surgery with cardiopulmonary bypass, prophylactic use of methylprednisolone did not significantly reduce the likelihood of a worse outcome in an adjusted analysis and was associated with postoperative development of hyperglycemia warranting insulin in a higher percentage of infants than placebo. (Funded by the National Center for Advancing Translational Sciences and others; STRESS ClinicalTrials.gov number, NCT03229538.).

Project description:BackgroundDexmedetomidine is a sedative agent that may have the potential to reduce the risk of post-intensive care syndrome (PICS). This study aimed to establish whether prophylactic nocturnal dexmedetomidine safely reduces postoperative PICS incidence and to develop an easy-to-use model for predicting the risk of PICS following cardiac surgery.MethodsThis was a single-center, double-blind, randomized, prospective, placebo-controlled trial. Patients undergoing cardiac surgery were randomly assigned (1:1) to dexmedetomidine or placebo (normal saline) groups between January 2019 and July 2020. Dexmedetomidine or a similar volume of saline was administered, with an infusion rate up to 1.2 μg/kg/h until the RASS remained between - 1 and 0. The primary study endpoint was PICS incidence at 6 months follow-up, as defined by cognitive, physical, or psychological impairments.ResultsWe assessed 703 individuals for eligibility, of whom 508 were enrolled. Of these, there were 251 in the dexmedetomidine group and 257 in the placebo group that received the trial agent, forming a modified intention-to-treat population. PICS incidence at 6-month follow-up was significantly decreased in the dexmedetomidine group (54/251, 21.5%) relative to the placebo group (80/257, 31.1%) (odds ratio [OR] 0.793, 95% CI 0.665-0.945; p = 0.014). Psychological impairment was significantly reduced in the dexmedetomidine group relative to the placebo group (18.7% vs. 26.8%, OR 0.806, CI 0.672-0.967, p = 0.029). However, dexmedetomidine treatment was associated with a higher rate of hypotension. A nomogram revealed that age, education, a medical history of diabetes and smoking, dexmedetomidine treatment, postoperative atrial fibrillation, and sequential organ failure assessment scores at 8 h post-surgery were independent predictors of PICS.ConclusionsProphylactic nocturnal dexmedetomidine administration significantly reduced PICS incidence by a marked reduction in psychological impairment within a 6-month follow-up period.Trial registrationChiCTR, ChiCTR1800014314 . Registered 5 January 2018, http://www.chictr.org.cn/index.aspx.

Project description:BackgroundNeurobehavioral disabilities occur in 5-15% of preterm infants with an estimated 50-70% of very low birth weight preterm infants experiencing later dysfunction, including cognitive, behavioral, and social delays that often persist into adulthood. Factors implicated in poor neurobehavioral and developmental outcomes are hospitalization in the neonatal intensive care unit (NICU) and inconsistent caregiving patterns. Although much underlying brain damage occurs in utero or shortly after birth, neuroprotective strategies can stop lesions from progressing, particularly when these strategies are used during the most sensitive periods of neural plasticity occurring months before term age. The purpose of this randomized trial is to test the effect of a patterned feeding experience on preterm infants' neurobehavioral organization and development, cognitive function, and clinical outcomes.MethodsThis trial uses an experimental, longitudinal, 2-group design with 120 preterm infants. Infants are enrolled within the first week of life and randomized to an experimental group receiving a patterned feeding experience from the first gavage feeding through discharge or to a control group receiving usual feeding care experience. The intervention involves a continuity of tactile experiences associated with feeding to train and build neuronal networks supportive of normal infant feeding experience. Primary outcomes are neurobehavioral organization as measured by Neurobehavioral Assessment of the Preterm Infant at 3 time points: the transition to oral feedings, NICU discharge, and 2 months corrected age. Secondary aims are cognitive function measured using the Bayley Scales of Infant and Toddler Development, Third Edition at 6 months corrected age, neurobehavioral development (sucking organization, feeding performance, and heart rate variability), and clinical outcomes (length of NICU stay and time to full oral feeding). The potential effects of demographic and biobehavioral factors (perinatal events and conditions of maternal or fetal/newborn origin and immunologic and genetic biomarkers) on the outcome variables will also be considered.DiscussionTheoretically, the intervention provided at a critical time in neurologic system development and associated with a recurring event (feeding) should enhance neural connections that may be important for later development, particularly language and other cognitive and neurobehavioral organization skills.Trial registrationNCT01577615 11 April 2012.

Project description:BackgroundVitamin D is a pleiotropic hormone important for the recovery of organ systems after critical illness. Recent observational studies have suggested that three out of every four children are vitamin D deficient following cardiac surgery, with inadequate preoperative intake and surgical losses playing important contributory roles. Observed associations between postoperative levels, cardiovascular dysfunction and clinical course suggest that perioperative optimization of vitamin D status could improve outcome. With this two-arm, parallel, double blind, randomized controlled trial (RCT), we aim to compare immediate postoperative vitamin D status in children requiring cardiopulmonary bypass for congenital heart disease who receive preoperative daily high dose vitamin D supplementation (high-dose arm) with those who receive usual intake (low-dose arm).Methods/designEligibility requirements include age (>36 weeks, <18 years) and a congenital heart defect requiring cardiopulmonary bypass surgical correction. Enrollment of 62 participants will take place at a single Canadian tertiary care center over a period of 2 years. Children randomized to the high-dose group will receive age-based dosing that was informed by the Institute of Medicine (IOM) daily tolerable upper intake level (<1 year old = 1,600 IU/day, >1 year old = 2,400 IU/day). Children in the low-dose arm will receive usual care based on IOM recommendations (<1 year old = 400 IU, >1 year old = 600 IU). The primary outcome measure is immediate postoperative vitamin D status, using blood 25(OH)D.DiscussionMaintaining adequate postoperative vitamin D levels following surgery could represent an effective therapy to speed recovery following CHD surgery. The proposed research project will determine whether preoperative supplementation with a dosing regimen based on the IOM recommended daily upper tolerable intake will prevent postoperative vitamin-D deficiency in the majority of children. The results will then be used to inform the design of a large international RCT exploring whether preoperative optimization of vitamin D status might improve short and long-term outcomes in this vulnerable population.Trial registrationClinicaltrials.gov Identifier--NCT01838447 Date of registration: 11 April 2013.

Dataset Information

Early high-energy feeding in infants following cardiac surgery: a randomized controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Early high-energy feeding in infants following cardiac surgery: a randomized controlled trial.

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