跳至主要内容
临床试验/CTRI/2023/08/057097
CTRI/2023/08/057097尚未招募不适用

A novel approach on representation of postnatal weight loss in healthy newborns-The Newborn Weight Loss Tool

Malabar Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2023年9月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
258
试验地点
1
主要终点
Participants will be visited in the postnatal ward during the hospital stay & data will be extracted on all weights obtained during birth hospitalisation as well as on gestational age, mode of delivery, maternal age, newborn sex, parity, type of feedings. Nomogram will be generated daily using the above inputs

研究概览

简要总结

Human milkis the optimal source of nutrition for all infants & exclusive breastfeeding is recommended for first 6 months of life. After birth newbornstypically lose weight steadily  until feeding is established. Weight lossup to 7-10% of birth weight is  encountered. Pronounced weight loss isassociated with hyperbilirubinemia and hypernatremic dehydration whichconstitute two most common causes of readmission. Monitoring a baby’s weight istherefore essential until lactation is established.

Newborn weight loss tool (NEWT)is a potential solution for detecting newborns who are on a trajectory forexcessive weight loss. This tool consist of nomogram that show hour by hourweight loss trajectories during birth hospitalisation for healthy newborns. Thenewborn weight loss tool is a free, publicly  available website thatdepicts a newborn’s weight loss  in the context of normative referencenomograms for weight loss at each hour of age. This can be used by manuallyentering new born data including weight. These nomograms can be used byclinicians to help guide infant feeding decisions. Participants will be visitedin postnatal ward during the hospital stay and weight will be monitored dailytill discharge; 48 hours in case of babies born by vaginal route and 96 hoursin those who are born by LSCS. Following data will be fed as input to the NEWTtool- birth weight, date of birth in MM/DD/YYYY format, birth time in 24 hourclock format and post birth weights and timing of these measurements. Nomogramwill be generated using the above inputs up to 48-96 hours.

While growth chart is anestablished  tool for the assessment of childhood nutrition and growth; asimilar plot for the postnatal weight loss is a recent development. Most of thestudies on postnatal weight loss are conducted on western population.Literature review revealed no Indian studies. Hence this study will provideinsights on Indian population on the same.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 4.00 Day(s)(—)
性别
All

入选标准

  • Inborn babies born at aster mims, calicut.

排除标准

  • Babies with major congenital anomalies Babies requiring NICU admission.

结局指标

主要结局

Participants will be visited in the postnatal ward during the hospital stay & data will be extracted on all weights obtained during birth hospitalisation as well as on gestational age, mode of delivery, maternal age, newborn sex, parity, type of feedings. Nomogram will be generated daily using the above inputs

时间窗: 48 hours weight monitoring in babies born by vaginal route, & 96 hours in those who are born by LSCS.

次要结局

  • The trend of weight loss in healthy newborns using the nomogram will help in guiding feeding interventions & also to identify the morbidities associated with significant weight loss in healthy newborns(4 days)

研究者

发起方
Malabar Institute of Medical Sciences
申办方类型
Research institution and hospital

研究点 (1)

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