scholarly journals Efficacy of oral erythromycin to enhance feeding tolerance in preterm infants

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.

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

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1670 ◽  
Author(s):  
Maria Elisabetta Baldassarre ◽  
Antonio Di Mauro ◽  
Osvaldo Montagna ◽  
Margherita Fanelli ◽  
Manuela Capozza ◽  
...  
Keyword(s):  
Gastric Emptying ◽  
Preterm Infants ◽  
Enteral Feeding ◽  
Controlled Trial ◽  
Pearson Correlation ◽  
Intact Protein ◽  
Feeding Success ◽  
Hydrolyzed Protein ◽  
To Receive ◽  
Full Enteral Feeding

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.

scholarly journals 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

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

scholarly journals Effects of Lactobacillus reuteri DSM 17938 in preterm infants: a double-blinded randomized controlled study

2019 ◽  
Vol 45 (1) ◽  
Author(s):  
Xuewei Cui ◽  
Yongyan Shi ◽  
Siyang Gao ◽  
Xindong Xue ◽  
Jianhua Fu
Keyword(s):  
Adverse Effects ◽  
Hospital Stay ◽  
Preterm Infants ◽  
Lactobacillus Reuteri ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Daily Weight Gain ◽  
Control Group ◽  
Early Feeding ◽  
Feeding Tolerance

Abstract Background Preterm infants have immature gastrointestinal tracts and poor immunity. In this study, the effects of Lactobacillus reuteri DSM 17938 first on early feeding tolerance, growth, and second on infection prevention in preterm infants were evaluated. Methods One hundred fourteen formula-fed preterm infants with a gestational age between 30 weeks and 37 weeks, and a birth weight between 1500 and 2000 g were enrolled; 57 in the intervention and 57 in the control group:the intervention group was given a dose of 1 × 108 colony-forming units (5 drops) of L. reuteri DSM 17938 once daily, beginning with the first feeding until discharge. The control group did not receive probiotics. Early feeding tolerance (as time to full enterla feeding and number of reflux), growth, incidences of sepsis, localized infection, NEC, and adverse effects were recorded for both groups. Results The number of Daily reflux episodes (times/d) was lower (2.18 ± 0.83 vs. 3.77 ± 0.66, P < 0.01) and time to full enteral feedings (120 mL/kg/d) (9.95 ± 2.46 d vs. 13.80 ± 3.47 d, P < 0.05) was shorter in the intervention group. Average daily weight gain (14.55 ± 3.07 g/d vs. 10.12 ± 2.80 g/d), head circumference increas e(0.0760 ± 0.0157 cm/d vs. 0.0681 ± 0.0108 cm/d), and body length increase (0.1878 ± 0.0151 cm/d vs. 0.1756 ± 0.0166 cm/d) of the intervention group were higher (P < 0.01). There were no significant differences in the incidences of sepsis (4.44% vs. 8.33%), localized infection (6.67% vs. 8.33%), or NEC (2.22% vs. 10.42%) between the 2 groups (P > 0.05). The number of daily defecations (times/d) in the intervention group was higher (3.08 ± 0.33 vs. 2.29 ± 0.20, P < 0.01) and the length of hospital stay was shorter than that in the control group (20.60 ± 5.36 d vs. 23.75 ± 8.57 d, P < 0.05). No adverse effects were noted among the infants receiving L. reuteri. Conclusion L. reuteri may be an useful tool in improving early feeding tolerance in preterm infants, promoting growth, increasing the frequency of defecation, and shortening the length of hospital stay. Trial registration ChiCTR, ChiCTR1900025590. Registered 1 February 2019- Retrospectively registered, http://www.chictr.org.cn/listbycreater.aspx.

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

2019 ◽  
Vol 16 (16) ◽  
pp. 2911 ◽  
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.

scholarly journals Efficacy of prednisolone for children with acute bronchiolitis having family history of atopy: A randomized placebo-controlled trial

2015 ◽  
Vol 6 (1) ◽  
pp. 9-11
Author(s):  
Md Abid Hossain Mollah ◽  
Khondokar Jahirul Hasan ◽  
M Ekhlasur Rahman ◽  
Shegufta Rahman
Keyword(s):  
Placebo Group ◽  
Family History ◽  
Hospital Stay ◽  
Oxygen Therapy ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Oral Prednisolone ◽  
Acute Bronchiolitis ◽  
Medical College ◽  
History Of

Objective : To determine the efficacy of oral prednisolone among children with acute bronchiolitis who have associated family history of atopy.Materials and Methods : This randomized double blind placebo controlled trial was carried out in Dhaka Medical College Hospital during July’08 to June’10. A total of sixty patients (1-24 months) of acute bronchiolitis who had family history of atopy (e.g. allergic rhinitis, allergic conjunctivitis, asthma, eczema) were enrolled. After enrollment, allocation of either prednisolone or placebo to the study subjects were done randomly by lottery method and the researcher remained blind about the allocation. Finally 30 cases received prednisoloneorally at a dose of 2mg/kg/day 8 hourly for 3 consecutive days and 30 cases received placebo (made of flour). In addition, both the groups got same supportive measures. During intervention, study subjects were monitored by Modified Respiratory Distress Assessment Instrument (MRDAI) score twice daily for consecutive 3 days. Duration of oxygen therapy as well as length of hospital stay was also determined. Data were analyzed using appropriate statistical tests and a p value of <0.05 was considered significant.Results : The respiratory rate, accessory muscle use and auscultatory finding scores were significantly declined in Prednisolone group than the placebo group (p<.05). However, cyanosis score though declined in both groups, the difference was not significant (p>.05). Mean duration of oxygen therapy needed in Prednisolone group was significantly lesser than the placebo group (13.7 vs 24.1 hours; P<.01). Similarly, the length of hospital stay was shorter in prednisolone group than in placebo group (3.3 vs 4.6days; p<.01).Conclusions : Three days of oral prednisolone therapy along with supportive measures was found to be significantly useful among children with acute bronchiolitis having family history of atopy in terms of clinical recovery, oxygen requirement and duration of hospital stayNorthern International Medical College Journal Vol.6(1) 2014: 9-11

scholarly journals The FEED1 Trial: Protocol for a Randomised Controlled Trial of Full Milk Feeds Versus Intravenous Fluids with Gradual Feeding for Preterm Infants (30-33 Weeks Gestational Age)

2021 ◽  
Author(s):  
Eleanor Jane Mitchell ◽  
Garry Meakin ◽  
Josie Anderson ◽  
Jon Dorling ◽  
Chris Gale ◽  
...  
Keyword(s):  
Breast Milk ◽  
Hospital Stay ◽  
Preterm Infants ◽  
Gestational Age ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Multiple Births ◽  
Primary Analysis ◽  
First Choice ◽  
Randomised Controlled

Abstract BackgroundIn the UK, approximately 8% of live births are preterm (before 37 weeks gestation), more than 90% of whom are born between 30 and 36 weeks, forming the largest proportion of a neonatal units’ workload. Neonatologists are cautious in initiating full milk feeds for preterm infants due to fears of necrotising enterocolitis (NEC). There is now evidence to dispute this fear. Small studies have shown that feeding preterm infants full milk feeds enterally from birth could result in a shorter length of hospital stay, which is important to parents, clinicians and NHS services without increasing the risk of NEC. This trial aims to investigate whether full milk feeds initiated in the first 24 hours after birth reduces the length of hospital stay in comparison to introduction of gradual milk feeding with IV fluids.MethodsFEED1 is a multi-centre, open, parallel group, randomised, controlled superiority trial of full milk feeds initiated on the day of birth versus gradual milk feeds for infants born at 30+0 to 32+6 (inclusive) weeks gestation. Recruitment will take place in around 40 UK neonatal units. Mothers will be randomised 1:1 to full milk feeds, starting at 60 ml/kg day, or gradual feeds, as per usual local practice. Mother’s expressed breast milk will always be the first choice of milk, though will likely be supplemented with formula or donor breast milk in the first few days. Feeding data will be collected until full milk feeds are achieved (>140 ml/kg/day for 3 consecutive days). The primary outcome is length of infant hospital stay. Additional data will be collected 6 weeks post-discharge. Follow-up at 2 years (corrected gestational age) is planned. The sample size is 2088 infants to detect a between group difference in length of stay of two days. Accounting for multiple births, this requires 1700 women to be recruited. Primary analysis will compare the length of hospital stay between groups, adjusting for minimisation variables and accounting for multiple births.DiscussionThis trial will provide high-quality evidence on feeding practices for preterm infants. Full milk feeds from day of birth could result in infants being discharged sooner.Trial RegistrationISRCTN, ISRCTN89654042 prospectively registered on 23 September 2019; http://www.isrctn.com/ISRCTN89654042

scholarly journals 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

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.

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

Trials ◽  
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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