跳至主要内容
临床试验/CTRI/2025/11/097323
CTRI/2025/11/097323尚未招募不适用

Complementary feeding practices in preterm infants-A cross sectional study

Dr Priya Hulamani1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年11月25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
112
试验地点
1
主要终点
Using World Health Organization infant and young feeding indicators such as:

研究概览

简要总结

Complementary feeding is defined as the process of providing food when breast milk or milk formula alone are no longer adequate to meet nutritional requirements. WHO recommends starting complementary feeding at 6 months of age and continues till 23 months. Breast feeding has to be continued along with complementary feeding. (4).  In LMIC’S National guidelines recommends complementary feeding begin at 6 months (4,64,65). After the age of 6 months, complementary feeding gives additional source of protein, iron, zinc, vitamin A and other essential micronutrients, prevents malnutrition, helps in cognitive, motor and socio-emotional development. reduces the risk of non-communicable diseases like Obesity, Type 1 diabetes. (14)

 According to the NFHS-5 data (2019–2021), in India, the percentage of children aged 6–8 months receiving solid or semi-solid food along with breastmilk is 52% in urban areas, 43.9% in rural areas, and 45.9% overall. Among breastfeeding children aged 6–23 months, only 11.8% received an adequate diet, while 12.7% of nonbreastfeeding children in the same age group received an adequate diet. Overall, only 11.3% of children aged 6– 23 months were reported to be receiving an adequate diet.

 In Karnataka, as per the NFHS-5 (2019–2020) data, 11.0% of breastfeeding children aged 6–23 months were receiving an adequate diet. Among non-breastfeeding children, this figure was 19.5%, with a total of 12.8% of children in this age group receiving an adequate diet.

 In Belgaum district, 35.6% of infants were introduced to complementary foods during their sixth month. Among mothers, 9.3% reported giving one complementary feed per day, 18% reported giving two feeds per day, while the remaining mothers reported giving complementary foods three or more times per day.(199)

 Preterm birth is defined as the birth of a baby before 37 completed weeks of gestation. Globally, the prevalence of prematurity is approximately 10–12%, and according to NFHS-5 data, the prevalence in India is around 12%. Prematurity is one of the leading causes of mortality and morbidity during the first year of life and contributes significantly to under-five mortality(2). In preterm infants, the development of a normal feeding pattern can be disrupted by extrauterine influences, resulting in dysphagia or abnormal swallowing. This may include impaired sucking, swallowing, or airway protection, which compromises the efficacy, adequacy, and most importantly, the safety of oral feeding. Dysphagia in preterm infants may reflect underlying anatomical or neurological abnormalities or injuries, or may simply be due to functional immaturity influenced by external sensory inputs(16). While feeding problems are seen in about 1% of the general pediatric population, the prevalence is significantly higher among preterm infants and is directly proportional to the degree of prematurity.(15) Residual feeding problems in growing preterm infants present with a wide range of phenotypes, including feeding tube dependency(30), nonspecific feeding difficulties, oral and feeding aversions(9,31,32). delayed transition to solid foods, difficulty with specific food textures (e.g., solids), and subtle swallowing dysfunctions. These feeding issues, compounded by delayed and inadequate nutrition, can lead to impaired growth and development in preterm infants.

A position paper done by Italian neonatal,paediatric and paediatric gastroenterology joint societies summarised current evidence regarding complementary feeding in preterm infants. However in India Guidelines for Complementry feeding not appropriate for preterm infants and lack of evidence-based recommendations and Indicators for adequate complementary feeding for preterm infants.

研究设计

研究类型
Observational

入排标准

年龄范围
11.00 Month(s) 至 13.00 Month(s)(—)
性别
All

入选标准

  • 1.Preterm Infants Of 11 to 13 Months (window period),born less than 37 weeks of gestatioal age and coming to Paediatric OPD and infants admitted in inpatient department.
  • 2.Parents/guardians of preterm infants who are giving consent for study.

排除标准

  • 1.Infants with congenital malformation affecting feeding e.g.-cleft palate and cleft palate and cleft lip,cerebral palsy,congenital heart disease.
  • 2.Infants with known chronic systemic diseases(e.g.GERD,Chronic kidney disease,tracheoesophageal fistula) 3.Sick infants requiring admission or immediate care.

结局指标

主要结局

Using World Health Organization infant and young feeding indicators such as:

时间窗: over a span of one year

MINIMUM DIETARY DIVERSITY(MMD)

时间窗: over a span of one year

MINIMUM MEAL FREQUENCY(MMF)

时间窗: over a span of one year

MINIMUM ACCEPTABLE DIET(MAD)

时间窗: over a span of one year

Percentage of infants who meet the criteria for each indicator will be calculated and identify factors associated with appropriate complementary feeding practices,and its outcome on improved infants health,reduced risk of malnutrition and long term well being of infants.

时间窗: over a span of one year

次要结局

  • Growth outcome of infants at 11 to 13 months age is analysed using anthropometric measurements and association between complementary feeding and growth of infants.(over span of one year)

研究者

发起方
Dr Priya Hulamani
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Priya Hulamani

Jawaharlal Nehru Medical College

研究点 (1)

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