Nutrition In Preoperative Pediatric Congenital Heart Disease: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 118
- 主要终点
- changing the nutritional status
研究概览
简要总结
Introduction: The use of a nutritional protocols provides the standardization of assessment procedures and the optimization of nutritional status recovery of pre-surgical infants with Congenital Heart Disease (CHD). However, to our knowledge there are no validated instrument for presurgical nutritional support for infants with congenital heart disease (CHD) in Brazil.
Objective: Assess the clinical effectiveness of the translated and cross-culturally adapted protocol, Nutritional Pathway for Infants with Congenital Heart Disease before Surgery (Marino et al., 2018), on the weight change of infants with congenital heart disease in two specialized cardiology hospitals in Southern Brazil in partnership with the UK research group that authored the original of protocol.
Methods: A randomized, pragmatic clinical trial will be carried out. The sample will consist of children with CHD, between 0-12 months of age, awaiting cardiovascular corrective surgery from the Pediatric Outpatient Clinic in the Institute of Cardiology (IC) and Children's Hospital Santo Antonio of Santa Casa de Misericordia. The previously translated pre-surgical nutritional intervention protocol for infants with congenital heart disease will be compared with current routine nutritional guidelines used in the follow-up services of children with congenital heart disease in these institutions within the national public healthcare, SUS.
Intended results: It is expected that the culturally-adapted pre-surgical nutritional support protocol for children with congenital heart disease will be effective in pre-surgical infant weight gain, which will likely improve surgical prognosis and clinical outcomes. And we hope that this protocol will promote the standardization of care, and will provide an empirically-based nutritional intervention that may improve the effectiveness of nutritional recovery in the CHD infants. Furthermore, the results may be used in the formulation of Brazilian guidelines for comprehensive care of children with congenital heart disease.
详细描述
OBJECTIVES
- Test the clinical effectiveness of the translation and adaptation of a pre-surgical nutritional intervention protocol for children with CHD on pre-surgical weight gain, as well as, compare it with the current clinical practice in Brazil.
- Assess the nutritional status of the participants;
A NUTRITIONAL PROTOCOL IN PRE-SURGICAL PEDIATRIC CONGENITAL HEART DISEASE IN BRAZIL: A RANDOMIZED PRAGMATIC CLINICAL TRIAL
DESIGN Randomized clinical trial, pragmatic, blinded for outcomes evaluation. Following the Consolidated Standards of Reporting Trials (CONSORT) guidelines for the writing of randomized clinical trials.
POPULATION The population from which the sample will be randomized will consist of children with congenital heart disease, aged from 0-12 months, in the pre-operative phase and from the Pediatrics Clinic of the Institute of Cardiology (IC), and Children's Hospital Santo Antonio, located in the city of Porto Alegre, RS, Brazil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, full blinding will not be possible. However, the statistical analysis team will be blinded.
入排标准
- 年龄范围
- 30 Days 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with a diagnosis of congenital heart disease aged between zero and twelve months, awaiting surgery for cardiac correction, classified in risk category 1 of the RACHS-1 score;
- •Term birth;
排除标准
- •Patients with:
- •Neurological impairment;
- •Craniofacial malformation;
- •Structural alterations of the upper airways;
- •Respiratory impairment;
- •Suspicion or diagnosis of genetic syndrome;
- •Any type of food allergy.
结局指标
主要结局
changing the nutritional status
时间窗: change in nutritional status after 60 days of preoperative intervention
Effectiveness of the cross-culturally adapted protocol on changing the nutritional status of babies with congenital heart disease
次要结局
未报告次要终点
研究者
Fernanda Lucchese
PHD
Instituto de Cardiologia do Rio Grande do Sul