Early add on enteral feeding VS standard feeding practice in late preterm and term infants at risk of hypoglycemia - A randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- incidence of hypoglycemia
研究概览
简要总结
Hypoglycemia is a frequently encountered metabolic problem in neonates. After birth,
neonates lose the continuous supply of transplacental glucose. A high brain-to-body weight
ratio along with developmental immaturity of adaptive mechanisms such as gluconeogenesis
and glycogenolysis further increase the chances of hypoglycemia in neonates. Symptoms of
hypoglycemia are nonspecific and include feeding difficulties, tachypnea, hypotonia, abnormal
cry, jitteriness, apnea, coma, and convulsions. Prolonged and repeated episodes of
hypoglycemia are associated with poor neurologic outcomes.
Exclusive breastfeeding is necessary to meet the metabolic needs of neonates, and any
delay in the early establishment of breastfeeding (eg, supplementing with water, glucose water,
or formula instead of breast milk) predisposes neonates to hypoglycemia. Poor latching to
the breast, decreased frequency of feeding, lack of support from health care workers for the
initiation of early breastfeeding and mother"s perception of having inadequate breast milk are
observed to be the predictors of neonatal hypoglycemia.
Neonates who are born premature, small for gestational age (SGA), have low birth
weight (LBW), and infant of diabetic mothers are at risk of hypoglycemia. In infants of diabetic
mother, in utero, maternal hyperglycemia increases placental glucose transport and results in
fetal hyperglycemia, which stimulates fetal pancreatic insulin production. After delivery,
maternal glucose supply ceases even though newborn insulin production continues and results
in hypoglycemia. Preterm infants have low glycogen and fat stores with limited capacity to
generate glucose via the gluconeogenesis pathway or excessive peripheral tissue utilization of
glucose resulting in hypoglycemia. SGA newborns have low hepatic glycogen storage,
increased glucose consumption due to disease stress, and unstable glucose metabolism
that could result in hypoglycemia.
These infants should be monitored for their blood glucose level (BGL) routinely, especially, in
the early hours of life. In addition, attention should be taken to initiate early enteral and or
parenteral nutrition to prevent hypoglycemia in these infants.
It is our unit practice to give exclusive breastfeeding to late preterm and term infants within
first hour of life in case of vaginal delivery and within four hours of life in case of caesarian
birth with plasma glucose level monitoring 4 to 6 hourly. Those infants with plasma glucose <
45mg/dL are initiated add-on feeds using expressed MOM OR formula feeds along with
breastfeeding. These infants may need add-on enteral feeds such as pasteurized donor human
milk or formula due to the deficient milk supply status of the mother in the early days of
postpartum. In addition, obstetric complications and hemodynamic instability also will affect
the milk production in some mothers
Given that the amount of colostrum produced within the first 72 hours postpartum is as low as
30-45 ml and minimal colostrum is being produced in the first day of life, exclusive
breastfeeding in high-risk infants in the first 3 days of life may lead to the need for parenteral
nutrition in many infants. Hence, we decided to study the effect of add-on feeding initiated
within the first hour of life with PDHM/ bovine formula along with breastfeeding on the incidence
of hypoglycemia in these at-risk infants in the first 3 days of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)(—)
- 性别
- All
入选标准
- •Gestational age more than 35 weeks with birth weight less than 2.5 kg Small for gestational age as per modified Fenton’s growth chart in preterm and WHO growth chart in term infants.
- •Large for gestational age infants Infants with birth weight at term >3.5 Kg Infant of diabetic mother.
排除标准
- •Antenatally diagnosed AEDF, major life threatening congenital anomalies, neonates requiring NICU admission shortly after birth, severe birth asphyxia, infants requiring oxygen support or respiratory support and surgical conditions, infants with feeding issues, infants with feeding issues like cleft palate, retrognathia, Pierre Robin sequence or on tubes feeds, infants with symptomatic hypoglycemia or asymptomatic with one hour prefeed sugar less than 35 mg/dL.
结局指标
主要结局
incidence of hypoglycemia
时间窗: 7 days
次要结局
- Requirement of intravenous glucose(7 days)
- Late onset sepsis(28 days)
- Duration of hospital stay(28 days)
- Neonatal hyperbilirubinemia requiring phototherapy(7 days)
- Time to regain birth weight(14 days)
- weekly gain of weight, length and head circumference(28 days)
- incidence of feed intolerence(28 days)
- incidence of exclusive breastfeeding till six months of age(6 months)
- Neurodevelopmental outcome at 1 year of age(1 year)
研究者
Anitha Haribalakrishna
Seth G.S. Medical College & KEM Hospital
