Rehabilitation of Severely Malnourished Infants Aged <6months: a Randomised, Controlled Comparison of Three Recovery Diets (Infant Formula, F-100 and Diluted F-100)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- rate of weight gain (g/kg/d)
研究概览
简要总结
Hypothesis:
During rehabilitation phase of management of severe acute malnourished Bangladeshi infants less than 6 months old, rates of weight gain will be significantly more in children fed F-100 and diluted F-100 compared to those fed infant formula.
Brief summary:
Until recently, severe malnutrition has been relatively rare in infants younger than 6 months, but with urbanization and the HIV/AIDS pandemic it is feared that the incidence of severe malnutrition among young infants will rise. The question of how best to feed infants aged <6 months has thus come to the forefront. Given the lack of published evidence regarding the most advantageous formulations for feeding severely malnourished infants aged <6 months, there is a need for observational studies and comparative randomized trials of alternative formulations to guide decisions about optimum dietary management in this age group. This area has been aptly considered a research priority during the consultation meeting of experts from all over the world convened by the World Health Organization on management of severe malnutrition in September 2004.
In the WHO case-management guidelines for severe malnutrition, there is no separate provision for young infants (infants less than 6 months old). The guidelines suggest the use of a low-solute formula (F-75) and continued breastfeeding in the initial stabilisation phase. In the rehabilitation phase, the guidelines advise F-100 with an energy density of 100kcal/100ml to promote catch-up growth. There is a concern that the renal solute load from using F-100 is too high for young infants, and some groups have started using diluted F-100 with an energy density of 75 kcal/100 ml.
Another related issue is the contribution of breastfeeding in dietary intakes during rehabilitation. In severely malnourished infants, breast milk intakes are likely to be low initially when appetite is poor, but may be substantial as the infant recovers. Uncertainty about breast milk intakes has led to conflicting opinions and advice, weaning from the breast as it is not providing sufficient energy (1).
The aim of this study, to be conducted in a carefully supervised Nutrition Rehabilitation Unit (NRU), will compare three recovery diets (Infant formula, F-100 and diluted F-100) in order to provide the evidence-base to determine if a change or add-on in terms of diet in the WHO guidelines is needed. It will also measure the potential renal solute load (mosmol/l), serum electrolytes and plasma osmolality of the same children. Body composition of the infants will also be measured using stable isotope dilution technique before and after the intervention diet is provided.
详细描述
Study design: This is a randomized controlled trial comparing three recovery diets and will be conducted at a Nutrition Rehabilitation Unit (NRU).
Duration of the study: 24 months. Study site: The trial will take place at the Dhaka Hospital of ICDDR, Bangladesh. This hospital has a high case load, peaking during April-October, and the WHO guidelines for the management of severely malnourished children with minor modifications are followed. Diarrhoea is the entry point for all patients attending the hospital including children.
Methods During the stabilization phase or the acute phase management, children will be fed every 2 hourly with 130ml/kg/day F-75 along with other necessary management according to WHO guidelines (8). Judgment regarding suitability for transfer to the rehabilitation phase will be made by the regular doctors at the longer-stay ward according to set criteria: i) return of appetite (i.e. hungry, easily finishes a feed), ii) naso-gastric feeding is not required, iii) absent or insignificant oedema, iv) cessation of vomiting, v) less than 3 watery stools/day, and vi) no clinical signs of infection.
When ready for the rehabilitation phase, eligible children will be transferred to the NRU and randomized to receive any of the three diets (Infant formula, F-100 or diluted F-100). For the first 2 days on the test diets, they will be fed 130ml/kg/day in 12 (2-hourly) feeds and then 10ml more at each feed until some is left. This is equivalent to the transition phase in the WHO guidelines. During these 2 days the infants' pulse and respiration rates will be monitored 3 hourly to find out the signs of possible fluid overload. Thereafter they will be fed at 3 hour intervals. Infants will be fed by trained research personnel and will be encouraged to eat until full. Being 'full' will be defined as two successive refusals when feed is re-offered. Water will be freely available between feeds. Breastfed children will continue to be breastfed. Pulse and respiration rates and temperature will be monitored every 8 hours. If, any of the infants shows the signs of fluid overload, they will be transferred to longer-stay or special care ward and will be managed according to the standardized management protocol practiced at Dhaka Hospital of ICDDR,B.
All the children who are accompanied by mothers will be counselled by professional breastfeeding counsellor for relactation if the child is already weaned from the breast.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They have a weight-for-length deficit of <-3SD and/or bi-pedal oedema on admission
- •They are less than 6 months old and have completed the initial stabilization phase
- •They are stabilized in less than 9 days (to exclude children who fail to respond to treatment)
- •Parental consent is obtained for enrollment in the study.
排除标准
- •Infants with congenital anomalies such as, congenital cardiac defects, cleft lip or palate or any other condition that interfering with feeding, chromosomal anomalies, and other organic problems including jaundice, tuberculosis etc. will be excluded.
研究组 & 干预措施
Infant Formula
A diet that is being fed to the young infants
干预措施: Infant Formula (Dietary Supplement)
Diluted F-100
300 ml of water is added to 1000 ml of F-100
干预措施: Diluted F-100 (Dietary Supplement)
结局指标
主要结局
rate of weight gain (g/kg/d)
时间窗: Duration of the hospital stay when the study participants will fulfill the discharge criteria. On an average of 2 weeks.
次要结局
未报告次要终点