Clinical trial NCT02187978: Early Total Enteral Feeding Versus Conventional Enteral Feeding in Stable Very Low Birth Weight Infants
Official title: Comparison of Early Total Enteral Feeding (ETEF) Versus Conventional Enteral Feeding (CEF) in Stable Very Low Birth Weight (VLBW) Infants - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition of Preterm Infants
Keywords: Early total enteral feeding (ETEF)
Conventional enteral feeding (CEF)
VLBW infants
NEC
Preterm infants
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2014-07-11
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the effect of early total oral feeding versus conventional oral feeding in stable VLBW infants. In current clinical practice, the introduction of oral feeds for VLBW infants is often preceded by a period of fasting or minimal feeding because of fear of necrotizing enterocolitis (NEC). However, this may be associated with potential disadvantages and increased infectious and metabolic complications related to prolonged fasting and use of parenteral nutrition. The studies conducted till date have shown better outcomes and improved postnatal growth with early initiation and fast advancements of feeds. It is still unclear whether stable VLBW babies can tolerate total oral feeds on day 1 of life. No such study has been conducted on early total oral feeding but observational work in our unit has shown it to be safe without any increased incidence of feed intolerance or NEC. In view of the uncertainties regarding feeding protocols in VLBW infants all over the world, the investigators decided to assess the effect of early total enteral feeding in stable VLBW infants.

Detailed description: Preterm VLBW infants often have negligible intrauterine reserves of nutrition along with a host of medical conditions postbirth including respiratory distress syndrome, hypoxia, hypotension, acidosis, infection and surgery. These conditions increase the metabolic energy requirements and nutrient needs of preterm babies. They require more specialised nutrition because of their faster growth rates; to correct the growth faltering post birth and to attain appropriate weight gain. Delayed postnatal growth due to inappropriate nutrition in early period leads to long term cognitive impairment and decreased school performance. Additional impediments to growth are high degree of biochemical and physiological immaturity of gastro intestinal tract with an immature immune system.

In current clinical practice, the introduction of progressive enteral feeds for preterm VLBW infants is often preceded by a period of enteral fasting or minimal enteral nutrition to decrease the incidence of NEC. However, there may also be potential disadvantages associated with delayed introduction of progressive enteral feeds. Gastrointestinal hormone secretion and motility is stimulated by enteral milk and hence delayed enteral feeding could diminish the functional adaptation of the gastrointestinal tract. In addition, 'starving' the gut may be harmful increasing susceptibility to infection due to impaired barrier function by intestinal epithelium. Parenteral nutrition (PN), though having an important role in early stabilization by allowing early calorie intake and preventing catabolism, is associated with significant risks of infectious and metabolic complications thereby increasing mortality and morbidity, prolonging hospital stay, and adversely affecting growth and development. As per recent literature reviews, enteral feeding has many advantages including appropriate intake of most nutrients. It also promotes growth and development of the gut and reduces the risk of infection. It is therefore important to establish enteral feeding as early as is safely possible. It has been argued that the risk of NEC should not be considered in isolation of these other potential clinical outcomes when determining feeding policies and practices for VLBW infants. A systematically conducted, randomized controlled trial is necessary to prove or refute the benefits of early total enteral feeding and nutrition. Hence the purpose of this prospective randomized controlled trial is to compare the benefits of early total enteral feeding over conventional enteral feeding in terms of attainment of full feeds, incidence of sepsis \& NEC and duration of hospital stay.

Eligibility criteria: Inclusion Criteria:

* Infants with gestational age between 28-34 weeks \& hemodynamically stable preterm VLBW neonates (B Wt. 1000-1499g) defined as
* No asphyxia(not required resuscitation beyond initial steps)
* No significant respiratory distress at randomization (Not requiring respiratory support)
* No clinical evidence of shock at the time of randomization (not requiring vasopressor support)

Exclusion Criteria

* Major Congenital malformation
* Refusal of consent
* AREDF in utero

Primary outcomes:
measure: Day of attaining 150mL/Kg of enteral feeds
timeFrame: Till 45 days of age
Secondary outcomes:
measure: Episodes of feed intolerance
timeFrame: Till 30 days of age or discharge whichever is earlier
Other outcomes:
measure: Incidence of Sepsis
timeFrame: Till 30 days of age or discharge whichever is earlier
measure: Duration of Hospital Stay
timeFrame: Till 45 days of age
measure: Mean weight at one month of age
timeFrame: one month of age
Locations:
city: New Delhi
country: India
facility: Lady Hardinge Medical College
state: Delhi
Study officials:
affiliation: Lady Hardinge Medical College & Kalawati Saran Children's Hospital
name: Sushma Nangia, MD,DM
role: PRINCIPAL_INVESTIGATOR
References: