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BMC Pediatrics Dec 2022Signs of feeding intolerance, such as gastrointestinal (GI) symptoms, are frequently observed in otherwise healthy formula-fed infants in the first months of life. The... (Observational Study)
Observational Study
BACKGROUND
Signs of feeding intolerance, such as gastrointestinal (GI) symptoms, are frequently observed in otherwise healthy formula-fed infants in the first months of life. The primary objective of this observational study was to examine GI tolerance in formula-fed infants (FFI) vs. breastfed infants (BFI) in a real-world setting with a secondary objective being the comparison of infants fed formula with pre- and/or probiotics (FFI_PP) and those fed formula without any pre- and/or probiotics (FFI_noPP) as well as BFI.
METHODS
A six-country, cross-sectional study in full-term exclusively/predominantly FFI (n = 2036) and BFI (n = 760) aged 6-16 weeks was conducted using the validated Infant Gastrointestinal Symptom Questionnaire (IGSQ) and a Feeding Practice and Gut Comfort Questionnaire.
RESULTS
The IGSQ composite score in FFI was non-inferior compared to BFI (mean difference [95%CI]: 0.17 [-0.34, 0.67]; non-inferiority p-value < 0.0001) and scores for BFI and FFI were below the threshold of 23, indicating no GI discomfort. Adjusted mean IGSQ scores ± SE were similar in FFI_PP (22.1 ± 0.2) and BFI (22.3 ± 0.3) while FFI_noPP (23.4 ± 0.3) was significantly higher and above 23 indicating some GI discomfort (mean differences [95%CI] FFI_noPP minus FFI_PP and FFI_noPP minus BFI were 1.28 [0.57, 1.98] and 1.09 [0.38, 1.80], respectively; both p < 0.01). Hard stools and difficulty in passing stool were more common in FFI compared to BFI (p < 0.01) but were less common in FFI_PP compared to FFI_noPP (p < 0.01). FFI_PP showed significantly less crying than FFI_noPP and was similar to BFI. Significantly fewer physician-confirmed colic episodes (Rome IV criteria) were reported in FFI_PP compared with FFI_noPP or BFI.
CONCLUSIONS
In this real-world observational study, FFI had non-inferior overall GI tolerance compared to BFI. Within FFI, infants receiving formulas with pre- and/or probiotics had a better GI tolerance, improved stooling and less infantile colic compared to those receiving formula without any pre- and/or probiotics and were more similar to BFI.
TRIAL REGISTRATION
NCT03703583, 12/10/2018 ( https://clinicaltrials.gov/ct2/show/NCT03703583 ).
Topics: Female; Infant; Infant, Newborn; Humans; Cross-Sectional Studies; Colic; Infant Formula; Breast Feeding; Gastrointestinal Diseases; Double-Blind Method
PubMed: 36514058
DOI: 10.1186/s12887-022-03763-8 -
Journal of Pediatric Gastroenterology... Jul 2024Functional gastrointestinal disorders (FGID), such as infant regurgitation, infant colic, and functional constipation, are common and typically physiological phenomena... (Review)
Review
Functional gastrointestinal disorders (FGID), such as infant regurgitation, infant colic, and functional constipation, are common and typically physiological phenomena during the early months of an infant's life and account for frequent consultations with pediatricians. Various infant formulas are marketed for their management and are frequently given by parents to infants before a medical consultation. However, the evidence supporting their effectiveness is limited and some have altered nutritional compositions when compared to standard formulas. Thus, these products should only be used under medical supervision and upon medical advice. Marketing and over-the-counter sales do not ensure proper medical guidance and supervision. The aim of this position paper is to review the current evidence regarding the safety and efficacy of formulas specifically formulated for addressing regurgitation, colic, and constipation, recognized as FGID. The objective is to provide guidance for clinical management based on the highest quality of available evidence. A wide search using Pubmed, MEDLINE, EMBASE and Cochrane Database of Systematic Reviews was performed including the MESH terms infant formula, colic, constipation, regurgitation, reflux, palmitate, lactase, lactose, magnesium, hydrolyzed protein, prebiotics or probiotics. 752 papers were identified and screened. Finally, 72 papers were included in the paper. In the absence of evidence, recommendations reflect the authors' combined expert opinion. Final consensus was obtained by multiple e-mail exchange and meetings of the Nutrition Committee. (1) For breastfed infants experiencing FGID such as regurgitation, colic, or constipation, transitioning from breastfeeding to commercial formulas is not recommended. (2) In general, whether an infant is breastfed or formula-fed, it's crucial to reassure parents that FGIDs are normal and typically do not necessitate treatment or change to a special formula. (3) Thickened formulas, often termed anti-reflux formulas, may be considered in specific cases of regurgitation. (4) The usage of specialized formulas for infants with colic is not advised due to a lack of clinical evidence. (5) In the case of constipation in infants, the use of formulas enriched with high β-palmitate and increased magnesium content may be considered to soften the stool. Generally, there is limited evidence supporting the use of specialized formulas for FGID. Breastfeeding should never be discontinued in favor of formula feeding.
Topics: Humans; Infant Formula; Infant; Gastrointestinal Diseases; Infant, Newborn; Constipation; Colic
PubMed: 38766683
DOI: 10.1002/jpn3.12240 -
Journal of Pediatric Nursing 2021Current methods for estimating infant crying time are potentially subject to error as they rely on parents to contemporaneously log and calculate crying time. Our aim...
PURPOSE
Current methods for estimating infant crying time are potentially subject to error as they rely on parents to contemporaneously log and calculate crying time. Our aim was to present the average daily infant crying times from a digital recording device, not dependent on parent-based measurement.
DESIGN AND METHODS
We conducted a descriptive longitudinal survey of infant crying times. Parents of healthy, term newborns were provided with voice-activated digital recording devices and asked to record infants continuously for randomly selected 24-hour periods during a 4 week time period. We analyzed the daily crying time for infants at different weeks of life.
RESULTS
Of 136 families approached, 28 (20.5%) families were consented with 3 families withdrawing and 5 families submitting incomplete datasets, leaving a total of 20 families with complete datasets. During the first week of life, the mean crying time was about 25 minutes/day, which remained stable for the next few weeks until five weeks of life, when mean crying time increased to almost 40 minutes/day with increasing variance.
CONCLUSIONS
In our study sample, infant mean daily crying times based on objective data were much less than estimates in recent studies.
PRACTICE IMPLICATIONS
This study suggests daily crying times measured by digital recorders are less than daily crying times based on parent diaries published in the literature. With the development of new 'apps' to record duration times, it may be clinically inappropriate to compare data based on digital recorders with norms from studies that use parent-reported crying times.
Topics: Colic; Crying; Humans; Infant; Infant, Newborn; Time Factors
PubMed: 33181371
DOI: 10.1016/j.pedn.2020.10.003 -
Microbial Pathogenesis Feb 2022A retrospective cohort study was conducted on two Egyptian horse farms with most of horses were suffered from abdominal pain to describe the associations between the...
A retrospective cohort study was conducted on two Egyptian horse farms with most of horses were suffered from abdominal pain to describe the associations between the occurrence of mycotoxicosis and equine colic. The farms owner complain was an unexpected increase in number of colic cases and deaths among horses. The association between colic and risk factors (sex, type of food either dry or mixed with roughages and hematobiochemical parameters) was compared using independent sample T-test. The associations between possible prognostic indicators for colic caused by mycotoxicosis was estimated using logistic regression analysis model. The cumulative incidence, incidence rates for colic attacks, survival rate among diseased horses were additionally estimated. Our results showed that a total of 24 out of the 132 horses suffered from colic due to feeding of ration contaminated with high percent of mycotoxin including Aflatoxins, Ochratoxins and or fusarium mycotoxins. The total cumulative incidence of colic due to mycotoxicosis was 19.7%. The horses fed on dry rations had more chance of developing colic than horses fed on mixed rations (P < 0.05). The overall incidence rate of colic due to mycotoxicosis was estimated at 18 colic attack/1000 horse/month. The mortality rate of horses suffered from colic due to mycotoxicosis was estimated at 5.9% (5/85), while the case fatality rate was estimated at 25% (n = 5/20). Inconclusion, our results showed that mycotoxicosis are considered an important risks factor for colic cases development in equine practice.
Topics: Animals; Colic; Horse Diseases; Horses; Mycotoxicosis; Retrospective Studies; Risk Factors
PubMed: 34974118
DOI: 10.1016/j.micpath.2021.105377 -
Equine Veterinary Journal Mar 2023Emergency laparotomies in donkeys are infrequently performed and there is limited literature on the subject.
BACKGROUND
Emergency laparotomies in donkeys are infrequently performed and there is limited literature on the subject.
OBJECTIVES
To determine findings and associated outcomes of exploratory laparotomies in donkeys.
STUDY DESIGN
Descriptive retrospective study.
METHODS
Donkeys undergoing emergency exploratory laparotomy for investigation and treatment of colic at seven UK referral hospitals between 2005-2017 were included. Data were retrieved from available hospital records. Descriptive statistics and inferential statistical analysis of outcomes of interest was performed in three steps.
RESULTS
Thirty-three cases fulfilled the inclusion criteria. Clinical signs on presentation were available for 32 donkeys, of which 53.1% (17/32) presented for investigation of colic while in 46.9% (15/32) the presenting complaint was non-specific. Primary lesion location included small intestine (42.4%, 14/33), large colon (39.3%, 13/33), caecum (6.1%, 2/33), stomach (6.1%, 2/33) and 6.1% (2/33) had multiple abnormal findings without a clear primary lesion. Overall survival to discharge was 54.5% (18/33). Five donkeys (15.2%, 5/33) were euthanased at surgery and of those recovering from general anaesthesia a further 35.7% (10/28) were euthanased or died prior to discharge. Six donkeys (21.4%, 6/28) required a second laparotomy of which 4 (66.7%, 4/6) survived. Post-operative complications occurred in 82.1% (23/28) of cases and included hyperlipaemia (42.9%, 12/28), incisional complications (21.4%, 6/28), ileus (21.4%, 6/28) and persistent colic (17.9%, 5/28). When adjusted for other complications, donkeys with primary gastric lesions were less likely to have presented with severe colic compared with those with primary small intestinal lesions (OR: 0.07, 95% CI 0.01-0.95, p = 0.05). Only age was positively associated with death prior to discharge (OR: 1.18, 95% CI 1.03-1.36, p = 0.02).
MAIN LIMITATIONS
Small sample size and retrospective design.
CONCLUSION
Donkeys with abdominal lesions may present with a range of signs often not including colic. Surgical findings were diverse and survival to discharge appears to be lower than in horses.
Topics: Horses; Animals; Retrospective Studies; Laparotomy; Colic; Equidae; Horse Diseases; Postoperative Complications; United Kingdom
PubMed: 35478419
DOI: 10.1111/evj.13578 -
The Veterinary Clinics of North... Aug 2019Intravenous lidocaine is widely used to prevent or treat postoperative ileus in horses. Clinical studies that support this approach are flawed and contradicted by... (Review)
Review
Intravenous lidocaine is widely used to prevent or treat postoperative ileus in horses. Clinical studies that support this approach are flawed and contradicted by others. Also, physical obstruction could be more important in causing postoperative reflux than postoperative ileus in the horse. The antiinflammatory properties of lidocaine and the role of inflammation from intestinal handling in the genesis of postoperative reflux are questionable. Because of cost and questionable efficacy of lidocaine, a well-designed clinical trial is required to support its continued use. However, lidocaine could be given to provide or enhance analgesia in selected cases with postoperative colic.
Topics: Anesthetics, Local; Animals; Colic; Horse Diseases; Horses; Ileus; Lidocaine; Pain Management; Postoperative Complications
PubMed: 31076222
DOI: 10.1016/j.cveq.2019.03.003 -
Equine Veterinary Journal Nov 2022
Topics: Animals; Colic; Horse Diseases; Horses
PubMed: 36044554
DOI: 10.1111/evj.13871 -
Journal of Pediatric Gastroenterology... Jul 2023Infants with gastroesophageal reflux disease (GERD)-like symptoms have been classically defined as having a wide array of symptoms. In these instances, anti-reflux...
OBJECTIVES
Infants with gastroesophageal reflux disease (GERD)-like symptoms have been classically defined as having a wide array of symptoms. In these instances, anti-reflux medications are ineffective and overprescribed. Rather these symptoms are more attributable to dysphagia and unsettledness/colic. To address these conditions at our center, both speech language pathologist (SLP) and/or occupational therapist (OT) have contributed to evaluation. We hypothesized that dysphagia and unsettledness/colic are highly prevalent, yet under recognized in this population.
METHODS
Full-term infants with typical development and under 6 months of age (N = 174) were included. Infants with suspected dysphagia and/or evident colic/unsettledness were evaluated by SLP and OT, respectively.
RESULTS
GERD-like symptoms were present in 109 infants with attributes of dysphagia in n = 46, unsettledness/colic in n = 37, and combined in n = 26.
CONCLUSION
A multidisciplinary approach, including SLP and OT, is recommended for the evaluation of infants with GERD-like symptoms.
Topics: Humans; Infant; Deglutition Disorders; Colic; Gastroesophageal Reflux
PubMed: 37084339
DOI: 10.1097/MPG.0000000000003802 -
Cureus Dec 2023Background Infantile colic is defined as severe pain in the abdominal region of a baby primarily due to gastrointestinal implications and is believed to self-resolve...
Background Infantile colic is defined as severe pain in the abdominal region of a baby primarily due to gastrointestinal implications and is believed to self-resolve with time. Recently established Rome IV criteria of diagnosis state that infantile colic should be diagnosed if there are symptoms like excessive crying, irritability and fussiness. Hence, this study aimed to assess the level of maternal awareness towards infantile colic in Saudi Arabia and to explore the relationship between the level of awareness and different socio-demographic factors like age, gender, nationality, etc. Methodology A cross-sectional study was carried out in Saudi Arabia from February to May 2021. An online self-administered questionnaire via Google Forms was used as the primary data collection tool. The generated link was randomly shared on electronic social media platforms including Facebook, WhatsApp, Telegram, and Twitter. Results A total of 425 participants were finally enrolled in the study. One-third of the participants (n=141, 33.2%) were aged more than 40 years and 399 were married (93.9%). Out of a total of 20 points, the mean score of maternal awareness was found to be 13.6±2.5. One-third of the participants (n=143, 33.6%) thought that rocking or carrying the baby would soothe the colic symptoms. Further, 175 participants (41.2%) used pain-relieving drugs and 7.8% sang lullabies. A total of 346 (81.4%) usually got frustrated/exhausted due to excessive crying sessions of the baby. Additionally, those who had received guidelines, educational programs or awareness sessions about the management of colic symptoms in babies had a significant awareness level (P-value = 0.032), while those who had not received education had poorer awareness. Conclusion Nearly one-third of the participants had good knowledge about infantile colic. More than one-third of the participants had previously received educational programs or awareness sessions about the management of colic symptoms in babies. More than half of the participants stated that postnatal maternal depression can occur as a result of infantile colic thereby psychological conflicts occur regarding the maternal role and inconsistent interaction styles with babies. Age, nationality, and marital status did not have a significant effect on the awareness level of the participants.
PubMed: 38213344
DOI: 10.7759/cureus.50364 -
Advances in Therapy Feb 2023Pain and spasms of urinary and biliary tracts are conditions causing poor quality of life. Treatment with analgesic drugs such as non-steroidal anti-inflammatory drugs...
Phloroglucinol-Derived Medications are Effective in Reducing Pain and Spasms of Urinary and Biliary Tracts: Results of Phase 3 Multicentre, Open-Label, Randomized, Comparative Studies of Clinical Effectiveness and Safety.
INTRODUCTION
Pain and spasms of urinary and biliary tracts are conditions causing poor quality of life. Treatment with analgesic drugs such as non-steroidal anti-inflammatory drugs and modulators of the parasympathetic system are not always tolerated, and often additional therapeutic options are necessary. The present analysis aimed to evaluate the pharmacokinetics and effectiveness of oral and parenteral preparations based on phloroglucinol in reducing pain and spasms associated with renal or biliary colic in phase 3, multicentre, open-label, randomized, comparative studies on clinical effectiveness and safety.
METHODS
Pharmacokinetic and pharmacodynamic studies were carried out. Four phase 3 multicentre, open-label, randomized, comparative studies were conducted to evaluate the clinical effectiveness and safety in patients with pain and spasms of urinary or biliary tracts. Eligible patients randomly received either phloroglucinol orally or via intramuscular (IM)/intravenous (IV) administration and reference drug, dexketoprofen for urinary spasms and pain, the non-steroidal anti-inflammatory drug metamizole or scopolamine-based reference drug for biliary colic. The primary outcomes were symptoms and observed frequency of spasms, while the secondary outcome was the duration of improvement or the time between the drug administration and the recurrence of symptoms. Comparison of groups by quantitative characteristics was performed using the T-test for independent samples or the Mann-Whitney test. Intragroup comparisons were performed using the Wilcoxon test, or the T-test for linked samples. Qualitative signs were analysed using the Pearson's χ test and Fisher's exact test.
RESULTS
The pharmacokinetic studies showed that (i) most of the phloroglucinol (> 80% for IV and per os formulations) was eliminated in the first 6 h after dosing, (ii) the drug was eliminated in urine as unchanged phloroglucinol (1,3,5-trihydroxybenzene) in a small proportion (< 3% of the dose) and (iii) a considerable amount of the drug was detected after enzymatic deconjugation with β-glucoronidase/arylsulfatase from Helix pomatia. As for the pharmacokinetic study, a total of 364 patients were enrolled, divided in four studies: two designed to test the effectiveness of oral and IM/IV preparations in biliary colic and two in urinary colic. Baseline characteristics between groups were similar. Phloroglucinol oral or IV/IM showed an effectiveness comparable to the reference drug in reducing pain and spasms associated with both urinary and biliary colic. There was no difference between all groups by survival analysis.
CONCLUSION
Oral and parenteral preparations based on phloroglucinol are as effective in reducing pain and spasms associated with renal or biliary colic as current therapeutic options. Therefore, phloroglucinol may be considered as useful to treat pain and spasms associated with urinary and biliary colic.
Topics: Humans; Colic; Phloroglucinol; Quality of Life; Anti-Inflammatory Agents, Non-Steroidal; Pain; Spasm; Treatment Outcome
PubMed: 36443585
DOI: 10.1007/s12325-022-02347-3