Early Total Enteral Feeding Versus Conventional Enteral Feeding in Stable Very Low Birth Weight Infants

Nutrition of Preterm Infants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187978
• Other study ID #: LHMC/098/2012/ETEF
• Status: Completed
• Phase: N/A
• First received: July 7, 2014
• Last updated: September 26, 2015
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Birth Weight
• Nutrition of Preterm Infants

Intervention

Other:
• Early total enteral feeding (ETEF)
In ETEF Group total required volume of fluid will be administered as oral feeds and no intravenous fluid will be given. Feeds will be started at 80 mL/kg and increased till 150ml/kg is attained.
• Conventional enteral feeding (CEF)
CEF Group will receive some feed and some Intravenous fluids. Feeds will be slowly increased from 20 mL/kg on day 1 till full feeds 150ml/kg is attained on day 6 of life.

Locations

Country	Name	City	State
India	Lady Hardinge Medical College	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Sepsis	Incidence of suspect (Clinical setting with positive sepsis screen) and confirmed (Clinical setting with positive blood culture) sepsis in the two groups	Till 30 days of age or discharge whichever is earlier	No
Other	Duration of Hospital Stay	The total duration of hospital stay till discharge alive from hospital will be calculated in completed number of days	Till 45 days of age	No
Other	Mean weight at one month of age	The difference in mean weight in grams at one month of age between the neonates of the two groups	one month of age	No
Primary	Day of attaining 150mL/Kg of enteral feeds	Full enteral feeds are defined as oral feeds at 150ml/Kg and sustaining it for 24 hrs	Till 45 days of age	No
Secondary	Episodes of feed intolerance	Feed intolerance defined as presence of 1 or more of the following; Vomiting >3 times during any 24 hr period; Any episode of bile/ blood stained vomiting; Abdominal girth (AG) increase > 2cm between feeds with pre feed gastric aspirate > 25% of pre feed volume (milk) or any amount hgic/bilious; Abdominal wall erythema; Gross blood in stools	Till 30 days of age or discharge whichever is earlier	No