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

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 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

Short versus Extended Duration of Trophic Feeding to Reduce Time to Achieve Full Enteral Feeding in Extremely Preterm Infants: An Observational Study

Neonatology ◽  
2017 ◽  
Vol 112 (3) ◽  
pp. 211-216 ◽  
Author(s):  
Ariel A. Salas ◽  
Nazia Kabani ◽  
Colm P. Travers ◽  
Vivien Phillips ◽  
Namasivayam Ambalavanan ◽  
...  
Keyword(s):  
Observational Study ◽  
Preterm Infants ◽  
Enteral Feeding ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Extended Duration ◽  
Full Enteral Feeding ◽  
Trophic Feeding

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 Early progressive feeding in extremely preterm infants: a randomized trial

2018 ◽  
Vol 107 (3) ◽  
pp. 365-370 ◽  
Author(s):  
Ariel A Salas ◽  
Peng Li ◽  
Kelli Parks ◽  
Charitharth V Lal ◽  
Camilia R Martin ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Enteral Feeding ◽  
Primary Outcome ◽  
Central Venous Access ◽  
Venous Access ◽  
Feeding Group ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Postmenstrual Age ◽  
Full Enteral Feeding

ABSTRACT Background Due to insufficient evidence, extremely preterm infants (≤28 wk of gestation) rarely receive early progressive feeding (small increments of feeding volumes between 1 and 4 d after birth). We hypothesized that early progressive feeding increases the number of full enteral feeding days in the first month after birth. Objective The aim of this study was to determine the feasibility and efficacy of early progressive feeding in extremely preterm infants. Design In this single-center randomized trial, extremely preterm infants born between September 2016 and June 2017 were randomly assigned to receive either early progressive feeding without trophic feeding (early feeding group) or delayed progressive feeding after a 4-d course of trophic feeding (delayed feeding group). Treatment allocation occurred before or on feeding day 1. The primary outcome was the number of full enteral feeding days in the first month after birth. Secondary outcomes were death, necrotizing enterocolitis (NEC), culture-proven sepsis, growth percentiles at 36 wk postmenstrual age, use of parenteral nutrition, and need for central venous access. Results Sixty infants were included (median gestational age: 26 wk; mean ± SD birth weight: 832 ± 253 g). The primary outcome differed between groups (median difference favoring the early feeding group: +2 d; 95% CI: 0, 3 d; P = 0.02). Early progressive feeding reduced the use of parenteral nutrition (4 compared with 8 d; P ≤ 0.01) and the need for central venous access (9 compared with 13 d; P ≤ 0.01). The outcome of culture-proven sepsis (10% compared with 27%; P = 0.18), restricted growth (weight, length, and head circumference <10th percentile) at 36 wk postmenstrual age (25% compared with 50%; P = 0.07), and the composite outcome of NEC or death (27% compared with 20%; P = 0.74) did not differ between groups. Conclusion Early progressive feeding increases the number of full enteral feeding days in extremely preterm infants. This trial was registered at www.clinicaltrials.gov as NCT02915549.

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.

The Effect of Individualized Developmental Care Practices in Preterm Infants

2019 ◽  
Vol 27 (2) ◽  
pp. 97-104
Author(s):  
Dilek Küçük Alemdar ◽  
Sevil İnal
Keyword(s):  
Breast Milk ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Oral Feeding ◽  
Control Group ◽  
Developmental Care ◽  
Significant Difference ◽  
Care Practices ◽  
Maternal Voice

Background: Preterm infants are vulnerable humans requiring much care and attention. They may be exposed to irregular noise, light, and odor in the neonatal intensive care unit for a period of several weeks or months. This study was carried out to determine the effect of individualized developmental care on physiological parameters, growth, and transition to oral feeding in preterm infants. Methods: The study was a randomized controlled trial. The sample comprised premature infants meeting the inclusion criteria. They were randomly assigned to four groups: the maternal voice group, the breast milk odor (BMO) group, the incubator cover (IC) group, and the control group. Results: No statistically significant difference was found between the groups in terms of weight, height, and head circumference at time of discharge. Mean SO2 values were statistically higher in the IC group than the other groups; however, the heart rate and respiratory rate were not statistically different in a significant sense between the groups. The briefest duration of transition to total oral feeding was seen in the BMO group. Conclusion: Individualized developmental care practices based on the results of these interventions are likely to support the care of preterm infants. Breast milk odor may ease the transition to breastfeeding.

Sign in / Sign up

Export Citation Format

Share Document