PEDIATRICS Vol. 100 No. 4 October 1997,
p. e4
Copyright ©1997 by the American Academy of Pediatrics
ELECTRONIC ARTICLE:
A Prospective Randomized Trial of Feeding Methods in Very Low
Birth Weight Infants
,
,
From the * Department of Pediatrics, Cook County Children's
Hospital;
Finch University Health Sciences/Chicago Medical School;
and § DePaul University, Chicago, Illinois.
Objective. To test the hypothesis that very low birth weight infants fed by continuous nasogastric gavage (CNG) would achieve full enteral feedings (100 kcal/kg/d) at an earlier postnatal age and have less feeding intolerance (FI) than infants fed by intermittent bolus gavage (IBG).
Methods. Eighty infants were stratified by birth weight (700 to 1000 g and 1001 to 1250 g) and randomized into CNG or IBG feeding groups. CNG infants were comparable with IBG in birth weight, gestational age, sex, race, and day of onset of feeding (5.7 ± 2.1 days vs 5.6 ± 2.2 days, respectively). Feedings were given as undiluted Similac Special Care formula (Ross Laboratories, Columbus, OH) via a specific protocol designed for each 50 to 100 g birth weight category. Feedings were advanced isoenergetically by a maximum of 25 mL/kg/d until an endpoint of 100/kcal/kg/d for at least 48 hours was reached. An infant whose feedings were withheld for >12 hours based on predetermined criteria was considered to have an episode of FI.
Results. Infants in the CNG group reached full enteral
feeding at 17.1 ± 8.9 days compared with 15.5 ± 5.5 days in
the IBG group; these were not statistically different. Secondary
outcome variables such as days to regain birth weight (CNG, 12.6 ± 5 days vs IBG, 12.5 ± 3.7 days), days to reach discharge
weight of 2040 g (CNG, 60 ± 13.4 days vs IBG, 62 ± 13.6 days), and number of episodes of FI were not significantly
different between feeding methods. FI was primarily associated with
birth weight
1000 g (71%) vs 1001 to 1250 g (38%).
Conclusion. Feeding methods are associated with similar outcomes when feeding regimens are comparable.
Key words: premature infants, feeding methods, feeding intolerance, gastric residual.Achievement of adequate nutrition, as soon as possible after birth, is the ultimate goal for all low birth weight infants (<1250 g); however, the best methods by which sufficient enteral nutrition can be provided remain controversial. Continuous nasogastric gavage (CNG) was introduced in 19721 and became widely accepted because of the ease of administration, the potential for sustaining growth,2 and the decreased time for steady weight gain.3 Advantages and disadvantages of different feeding methods have been proposed.4,5 In a survey of neonatologists in 1985, intermittent bolus gavage (IBG) was the preferred method of feeding low birth weight infants.6 Prospective controlled studies comparing these two methods are limited in number and either do not focus on very low birth weight infants (<1250 g) or do not include similar isoenergetic feeding protocols.
This study was designed to test the hypothesis that infants who weigh between 700 and 1250 g and are fed by CNG would have improved feeding tolerance and, therefore, would reach full enteral feedings at an earlier postnatal age than those fed by IBG.
The study was conducted between April 1994 and July 1995 in neonates admitted to the Neonatal Intensive Care Unit of Cook County Children's Hospital. The study design and consent forms were approved by the Internal Review Board of Cook County Hospital and informed consent was obtained from either of the parents when the infant was considered eligible for entry into the study.
Eligibility
Patients were eligible for enrollment if their birth weight was between 700 to 1250 g, if they had a soft abdomen and bowel sounds were present, and were considered by the attending neonatologist to be in a hemodynamically stable condition and ready to start enteral nutrition. The infant was included if still on a ventilator but feedings were not started until the umbilical arterial catheter was removed. Exclusion criteria were: Apgar score <3 at 5 minutes, mother had chosen to breastfeed, documented sepsis, necrotizing enterocolitis (NEC), or inability to start feedings before the tenth day of postnatal life. Once enrolled, patients were removed from the study if the route of feeding was changed in error or if the infant required a special formula, developed NEC, was transferred back to the referring hospital, or died before reaching full enteral feedings. All complications were noted even if the feeding data could not be included in the analysis.Protocol
The infants were stratified according to birth weight into one of two groups (Group A weighed between 700 and 1000 g and Group B weighed between 1001 and 1250 g). Infants were randomly assigned within each weight group to either CNG or IBG by using sequentially numbered opaque sealed envelopes using a table of random numbers. CNG feedings were delivered via an indwelling 5F polyvinyl nasogastric catheter with a continuous infusion pump (IVAC Medsystem III, San Diego, CA). IBG feedings were given by gravity every 3 hours for 15 to 30 minutes via an indwelling 5F nasogastric catheter similar to that used for CNG. Positioning of the nasogastric tube was not routinely confirmed by radiographs. Catheters in both groups were changed every 3 days per standard nursery protocol. Nonnutritive sucking was continued in both groups of infants to lessen behavioral distress.7 Gastric residual (GR) was measured with the same catheter every 2 hours in the CNG group and every 3 hours (prefeed) in the IBG group as currently practiced in our nursery. All infants were maintained in closed incubators until they weighed approximately 1800 g and the neonatal staff followed standard nursery protocols other than for feeding.
Table 1.
Feeding Protocol
Statistical Analysis
Based on the data of Krishnan et al,3 we hypothesized that CNG feedings would result in a 35% decrease in the number of days required to reach full enteral feedings (primary outcome) as compared with IBG feedings. The sample size, based on an
of .05 and a
error of .20, was calculated to be 70 patients. For continuous measures, the two groups were compared using the unpaired Student's t test adjusting for unequal variances
if necessary. Categorical measures were compared using the
2 test or Fisher's exact test when the expected cell
sizes were not adequate to meet the test assumptions. All results are
reported as mean ± standard deviation.
Ninety-one patients were eligible for the study and 89 were enrolled. Of the 2 patients who were not enrolled, 1 had developed NEC and the other was fed before consent could be obtained. Of the 89 enrolled, 9 (4 CNG and 5 IBG) were not included in the data analysis for the following reasons: of the 4 CNG patients, 2 were diagnosed as having severe congenital syphilis, 1 had been switched to breastfeeding, and 1 required surgery for intestinal malrotation. Of the 5 IBG patients, the protocol had not been followed in 3 patients, 1 patient had been switched to breastfeeding, and 1 was transferred to another hospital before completing the protocol. There were no deaths among the 89 infants and no other adverse outcomes.
Table 2.
Demographic Characteristics
1000 g at birth and 40 who weighed between
1001 and 1250 g at birth. No significant differences were seen
between the CNG and IBG groups at the onset of the study. Feedings were initiated in the CNG group at 5.7 ± 2.1 days and in the IBG at 5.6 ± 2.2 days.
Table 3.
Analysis of Outcome Based on Weight Groups
Table 4.
Comparison of Infants With and Without Feeding Intolerance (FI)
This study did not confirm our hypothesis that continuous nasogastric feedings would result in a decreased amount of time to achieve full feedings of 100 kcal/kg/d. There were also no significant differences between CNG and IBG methods in days to achieve full feedings nor in time to regain birth weight or to reach discharge weight. These findings are in contrast to those reported in abstract by Krishnan and Satish;3 however, their study was retrospective and not controlled for energy intake. Our results extend the findings of Silvestre et al11 who defined full enteral feedings as 75 kcal/kg/d and discharge weight as 1800 g; in their study there were also no differences between feeding methods in growth and macronutrient retention. Infants were approximately 100 g heavier than in our study and were started on enteral feedings while the umbilical catheter was still in place. Toce et al12 used a 20 cal/oz isoenergetic regimen and showed improvement in weight gain in only one subgroup of infants (1000 to 1249 g); there were no differences in infants >1250 g nor in the 10 infants who were <1000 g; all were off the ventilator when feeding protocols were begun. Urrutia and Poole13 reported, in an abstract, similar results between feeding methods in infants <1500 g. Symington et al14 also found no differences between the feeding methods but recommended continuous feeding as less expensive because the catheters in the intermittent group were removed after every feeding. In our study, catheters were replaced every 3 days in both groups of patients; hence cost of catheters was not a serious issue. Bolus feeding on the other hand, was considered superior to continuous feeding by Schanler et al,15 but the study was not controlled and FI was defined solely on the basis of GR.
Received for publication Jun 11, 1996; accepted Apr 21, 1997.
Presented in part at the annual meeting of the American Pediatric Society and the Society for Pediatric Research, Washington, DC, May 1996.
Reprint requests to (M.K.) Cook County Children's Hospital, Division of Neonatology, 700 South Wood St, Chicago, IL 60612.
CNG, continuous nasogastric gavage. IBG, intermittent bolus gavage. NEC, necrotizing enterocolitis. GR, gastric residual. FI, feeding intolerance.
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Pediatrics (ISSN 0031 4005). Copyright ©1997 by the American Academy of Pediatrics
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