Faster Gastric Emptying Is Unrelated to Feeding Success in Preterm Infants: Randomized Controlled Trial

Objectives: To evaluate the relationship between gastric emptying (GE) time and days to achievement of full enteral feeding (≥140 mL/kg/day) in preterm infants randomly assigned to receive one of two marketed study formulas for the first 14 feeding days: intact protein premature formula (IPF) or extensively hydrolyzed protein (EHF) formula. Methods: In this triple-blind, controlled, prospective, clinical trial, we report GE time (time to half-emptying, t1/2) by real-time ultrasonography on Study Day 14, in preterm infants receiving IPF or EHF formula. The association between GE time and achievement of full enteral feeding was evaluated by Pearson correlation. Per-protocol populations for analysis included participants who (1) completed the study (overall) and (2) who received ≥ 75% study formula intake (mL/kg/day). Results: Median GE time at Day 14 was significantly faster for the EHF vs. IPF group overall and in participants who received ≥ 75% study formula intake (p ≤ 0.018). However, we demonstrated GE time had no correlation with the achievement of full enteral feeding (r = 0.08; p = 0.547). Conclusion: Feeding IP premature formula vs. EH formula was associated with shorter time to full enteral feeding. However, faster GE time did not predict feeding success and may not be a clinically relevant surrogate for assessing feeding tolerance.

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Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16162911 ◽

2019 ◽

Vol 16 (16) ◽

pp. 2911 ◽

Cited By ~ 2

Author(s):

Maria Elisabetta Baldassarre ◽

Antonio Di Mauro ◽

Margherita Fanelli ◽

Manuela Capozza ◽

Jennifer L. Wampler ◽

...

Keyword(s):

Breast Milk ◽

Preterm Infants ◽

Enteral Feeding ◽

Primary Outcome ◽

Controlled Trial ◽

Intact Protein ◽

Group Differences ◽

Preterm Formula ◽

Hydrolyzed Formula ◽

Full Enteral Feeding

Background: This study was carried out to evaluate enteral feeding advancement and tolerance in preterm infants receiving one of two marketed formulas: intact protein preterm formula (IPF) or extensively hydrolyzed formula (EHF) for the first 14 feeding days. Methods: Primary outcome was days to full enteral feeding (≥140 mL/kg/day). Per protocol analyses included the following: all participants who met study entrance criteria and completed study feeding (primary) and those who received ≥75% enteral intake from study formula (subset). Mothers were encouraged to provide their breast milk. Results: Of the 65 enrolled (IPF: n = 32; EHF: n = 33), 60 completed study feeding per protocol (IPF: n = 30; EHF: n = 30), 37 (62%) received predominantly breast milk, and 23 (38%) received ≥75% study formula intake (IPF: n = 11; EHF: n = 12). No group differences were detected in tolerance measures. No necrotizing enterocolitis (NEC) was reported. Median time to achievement of full enteral feeding was significantly shorter for the IPF vs. EHF group (day 10 vs. 14, p < 0.05) (subset analysis). Mean enteral intake significantly increased by day 14 for the IPF group (p < 0.05), reflecting group divergence as achieved feeding volumes increased. Conclusions: Results suggest shorter time to full enteral feeding and higher feeding volume achieved by study end in preterm infants receiving intact protein preterm formula versus extensively hydrolyzed formula.

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Oropharyngeal Administration of Colostrum for Preventing Necrotizing Enterocolitis and Late-onset Sepsis in Preterm Infants with Gestational Age ≤ 32 Weeks: A Single-center Randomized Controlled Trial

10.21203/rs.3.rs-145820/v1 ◽

2021 ◽

Author(s):

xia ouyang ◽

changyi yang ◽

wenlong xiu ◽

yanhua hu ◽

susu mei ◽

...

Keyword(s):

Preterm Infants ◽

Necrotizing Enterocolitis ◽

Enteral Feeding ◽

Gestational Age ◽

Late Onset ◽

Controlled Trial ◽

Control Group ◽

Clinical Trial Registry ◽

Late Onset Sepsis ◽

Full Enteral Feeding

Abstract BackgroundOropharyngeal administration of colostrum (OAC) may provide immunoprotective and anti-inflammatory effects that potentially reduce the incidence of necrotizing enterocolitis (NEC) and late-onset sepsis (LOS) and improve short-term outcomes.ObjectiveTo evaluate the role of OAC in the early prevention of NEC and LOS in preterm infants with gestational age (GA) ≤ 32 weeks.MethodsA randomized, placebo-controlled trial was conducted in a 40-bed tertiary neonatal intensive care unit (NICU) in China. Preterm infants with GA ≤ 32 weeks were divided randomly into an OAC group, which received 0.4 ml maternal colostrum smearing via the oropharyngeal route every 3 hours for 10 days beginning within the first 48 hours after birth, and a control group, which received normal saline instead. Data from the two groups were collected and compared.ResultsA total of 127 patients in the OAC group and 125 patients in the control group were finally enrolled. The incidence of NEC (Bell stage 2 or 3) and LOS was lower in the OAC group [2.4% vs. 10.4%, χ2 = 6.845, ༰=0.009; 4.7% vs. 13.6%, χ2 = 5.983, ༰=0.014]. In addition, the incidence of intraventricular hemorrhage (IVH) (stage 3 or 4) was lower [1.6% vs. 7.2%,χ2 = 4.775, ༰=0.029], and the time of achieving full enteral feeding was shorter [ 22.0 days vs. 25.0 days༌Z = 6༌424.500༌P = 0.009)] in the OAC group. No cases of adverse reactions were observed in either group.ConclusionsOAC is a safe and simple NICU procedure that yields a potential advantage in decreasing the incidence of NEC, LOS, and severe IVH and shortening the time to achieve full enteral feeding in preterm infants with GA ≤ 32 weeks.Trial registrationChinese Clinical Trial Registry, ChiCTR1900023697, Registered 8 June 2019, Retrospectively registered, http://www.chictr.org.cn/edit.aspx? pid = 39398

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Efficacy of oral erythromycin to enhance feeding tolerance in preterm infants

Paediatrica Indonesiana ◽

10.14238/pi57.3.2017.154-9 ◽

2017 ◽

Vol 57 (3) ◽

pp. 154

Author(s):

Made Sukmawati ◽

Rinawati Rohsiswatmo ◽

Rulina Suradi ◽

Pramita Gayatri

Keyword(s):

Placebo Group ◽

Hospital Stay ◽

Preterm Infants ◽

Enteral Feeding ◽

Controlled Trial ◽

Length Of Hospital Stay ◽

Feeding Intolerance ◽

Body Weights ◽

Full Enteral Feeding ◽

Feeding Tolerance

Background Feeding intolerance is a common condition that affects preterm infants. Erythromycin is a prokinetic agent used to treat feeding intolerance, but its efficacy remains inconclusive.Objective To evaluate the effectiveness of oral erythromycin to enhance feeding tolerance in preterm infants.Methods This prospective, randomized controlled trial in preterm infants was conducted at Sanglah Hospital, Denpasar, Bali, from June 2015 to January 2016. Eligible infants were randomized to receive either 12.5 mg/kg/dose oral erythromycin or a placebo, every 8 hours. The primary outcome was the time to establish full enteral feeding. The secondary outcomes were body weight at full enteral feeding and length of hospital stay.Results Of 62 initial subjects, 3 infants dropped out of the study. Thirty infants were given erythromycin and 29 infants were given placebo. The baseline characteristics of the two groups were similar, with mean of gestational ages of 31.4 (SD 1.7) weeks in the erythromycin group and 32.4 (SD 2.2) weeks in the placebo group. The median times to reach full enteral feeding did not significantly differ between the two groups, with 10 (SD 5.3) days in the erythromycin group vs. 8 (SD 6.5) days in the placebo group (P=0.345). Also, median body weights at full enteral feeding and lengths of hospital stay were not significantly different between the two groups.Conclusion Erythromycin of 12.5 mg/kg/dose every 8 hours as prophylactic treatment does not significantly enhance feeding tolerance in preterm infants. Median body weights at full enteral feeding and length of hospital stay are not significantly different between the erythromycin and placebo groups.

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Oropharyngeal administration of colostrum for preventing necrotizing enterocolitis and late-onset sepsis in preterm infants with gestational age ≤ 32 weeks: a pilot single-center randomized controlled trial

International Breastfeeding Journal ◽

10.1186/s13006-021-00408-x ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Xia OuYang ◽

Chang-Yi Yang ◽

Wen-Long Xiu ◽

Yan-Hua Hu ◽

Su-Su Mei ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Preterm Infants ◽

Enteral Feeding ◽

Late Onset ◽

Controlled Trial ◽

Control Group ◽

Single Center ◽

Randomized Controlled ◽

Late Onset Sepsis ◽

Full Enteral Feeding

Abstract Background Oropharyngeal administration of colostrum (OAC) may provide immunoprotective and anti-inflammatory effects that potentially reduce the incidence of necrotizing enterocolitis (NEC) and late-onset sepsis and improve short-term outcomes. Our objective was to evaluate the role of OAC in the early prevention of NEC and late-onset sepsis in preterm infants with gestational age (GA) ≤ 32 weeks. Methods A pilot, single-center, 1:1 parallel randomized controlled trial was conducted in a 40-bed tertiary neonatal intensive care unit (NICU) in China from 1 January 2019 to 30 September 2020. Preterm infants were randomly divided into two groups with GA ≤ 32 weeks. The OAC group included preterm infants who received 0.4 ml of maternal colostrum via the oropharyngeal route every 3 h for 10 days beginning within the first 48 h after birth, and the control group included preterm infants who received normal saline instead. Data from the two groups were collected and compared. Results A total of 127 infants in the OAC group and 125 infants in the control group were enrolled. The incidence of NEC (Bell stage 2 or 3) and late-onset sepsis were lower in the OAC group [2.36% vs. 10.40%, relative risk (RR) 0.23 (95% confidence interval (CI) 0.07, 0.78), adjusted RR 0.23 (95% CI 0.06, 0.84); 4.72% vs. 13.60%, RR 0.35 (95% CI 0.14, 0.85), adjusted RR 0.36 (95% CI 0.14, 0.95)]. In addition, the incidence of proven sepsis and intraventricular hemorrhage (IVH) (stage 3 or 4) were lower in the OAC group [2.36% vs. 8.80%, RR 0.27 (95% CI 0.08, 0.94); 1.57% vs. 7.20%, RR 0.22 (95% CI 0.05, 0.99)], and the time to achieve full enteral feeding was shorter (23.13 ± 9.45 days vs. 28.50 ± 14.80 days). No adverse reactions were observed in either group. Conclusions Oropharyngeal administration of colostrum is a safe and simple NICU procedure that may yield a potential effect in decreasing the incidences of NEC, late-onset sepsis, and severe IVH and shorten the time to achieve full enteral feeding in preterm infants with GA ≤ 32 weeks. Trial registration Chinese Clinical Trial Registry, ChiCTR1900023697, Registered 8 June 2019, retrospectively registered.

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Faster gastric emptying is not related to shorter time to full enteral feedings: A pilot study on effects of an extensively hydrolyzed protein vs. intact protein formula in preterm infants

Digestive and Liver Disease ◽

10.1016/j.dld.2017.09.119 ◽

2017 ◽

Vol 49 (4) ◽

pp. e286

Author(s):

M.E. Baldassarre ◽

A. Di Mauro ◽

M. Capozza ◽

O. Montagna ◽

M. Fanelli ◽

...

Keyword(s):

Gastric Emptying ◽

Pilot Study ◽

Preterm Infants ◽

Intact Protein ◽

Hydrolyzed Protein ◽

Enteral Feedings

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Clinical effects of breast milk enema on meconium evacuation in premature infants: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05261-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Liqiang Zheng ◽

Li Gai ◽

Jinyue Gao ◽

Chaonan Kong ◽

Yali Wang ◽

...

Keyword(s):

Breast Milk ◽

Preterm Infants ◽

Premature Infants ◽

Enteral Feeding ◽

Controlled Trial ◽

Block Design ◽

Clinical Effects ◽

Study Results ◽

Extremely Preterm ◽

Full Enteral Feeding

Abstract Background Delayed meconium evacuation is an important cause of intestinal dysfunction in preterm infants. There are many methods to induce defecation in preterm infants: however, the effects are controversial. Finding a new intervention method to promote meconium evacuation in premature infants is necessary. Therefore, in the proposed study, the effectiveness of breast milk enema on complete meconium evacuation and time to achieve full enteral feeding will be investigated in preterm infants. Methods/design The study is a randomized, open-label, parallel-group, and single-center clinical trial. A total of 294 preterm infants will be recruited and stratified based on gestational age. Then, the infants will be assigned in a randomized block design to the intervention and control groups with a 1:1 ratio. Preterm infants in the control and intervention groups will receive saline enema and breast milk enema, respectively. The primary outcomes will be the time to achieve complete meconium evacuation from birth and time to achieve full enteral feeding from birth in preterm infants. The secondary outcomes will include hospitalization days, body weight at discharge, duration of total parenteral nutrition, cholestasis, and adverse events. Discussion The results of this trial will determine whether breast milk enema shortens the time to complete meconium evacuation and the time to achieve full enteral feeding in extremely preterm and preterm infants. Furthermore, the study results may provide a new, safe, inexpensive, and easy-to-use intervention to effectively evacuate meconium in preterm infants. Trial registration ISRCTN Registry ISRCTN17847514. Registered on September 14, 2019

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