scholarly journals The effect of smell and taste of milk during tube feeding of preterm infants (the Taste trial): a protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e027805 ◽  
Author(s):  
Friederike Beker ◽  
Judith Macey ◽  
Helen Liley ◽  
Ian Hughes ◽  
Peter G Davis ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Late Onset ◽  
Controlled Trial ◽  
Tube Feeding ◽  
Growth Failure ◽  
Neurodevelopmental Outcomes ◽  
Very Preterm Infants ◽  
Reference Number ◽  
Discharge From Hospital

IntroductionSmell and taste of milk are not generally considered when tube feeding preterm infants. Preterm infants have rapid growth, particularly of the brain, and high caloric needs. Enteral feeding is often poorly tolerated which may lead to growth failure and long-term neurodevelopmental impairment. Smell and taste are strong stimulators of digestion and metabolism. We hypothesise that regular smell and taste during tube feeding will improve weight z-scores of very preterm infants at discharge from hospital.Methods and analysisTaste is a randomised, unblinded two-centre trial. Infants born at <29 weeks’ gestation and/or <1250 g at birth and admitted to a participating neonatal intensive care unit are eligible. Randomisation occurs before infants receive two hourly feeds for 24 hours. Infants are randomised to either smell and taste of milk with each tube feed or tube feeding without the provision of smell and taste. The primary outcome is weight z-score at discharge. Secondary outcomes include: days to full enteral feeds, duration of parenteral nutrition, rate of late-onset sepsis, post menstrual age at removal of nasogastric tube and at discharge from hospital, anthropometric data and neurodevelopmental outcomes at 2 years of corrected age.Ethics and disseminationHuman Research Ethics Committees of Mater Misericordiae (trial reference number: HREC/16/MHS/112) and the Royal Women’s Hospital (trial reference number: 17/21) last approved the trial protocol (version 4.2; Date: 18 December 2018) and recruitment commenced in May 2017 and November 2017, respectively. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences.Trial registration numberACTRN12617000583347.

Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial

2021 ◽  
pp. fetalneonatal-2021-321945
Author(s):  
Ju Sun Heo ◽  
Ee-Kyung Kim ◽  
Sae Yun Kim ◽  
In Gyu Song ◽  
Young Mi Yoon ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Tube Feeding ◽  
Tertiary Hospital ◽  
Oral Feeding ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomised Controlled

ObjectiveTo evaluate the effects of direct swallowing training (DST) alone and combined with oral sensorimotor stimulation (OSMS) on oral feeding ability in very preterm infants.DesignBlinded, parallel group, randomised controlled trial (1:1:1).SettingNeonatal intensive care unit of a South Korean tertiary hospital.ParticipantsPreterm infants born at <32 weeks of gestation who achieved full tube feeding.InterventionsTwo sessions per day were provided according to the randomly assigned groups (control: two times per day sham intervention; DST: DST and sham interventions, each once a day; DST+OSMS: DST and OSMS interventions, each once a day).Primary outcomeTime from start to independent oral feeding (IOF).ResultsAnalyses were conducted in 186 participants based on modified intention-to-treat (63 control; 63 DST; 60 DST+OSMS). The mean time from start to IOF differed significantly between the control, DST and DST+OSMS groups (21.1, 17.2 and 14.8 days, respectively, p=0.02). Compared with non-intervention, DST+OSMS significantly shortened the time from start to IOF (effect size: −0.49; 95% CI: −0.86 to –0.14; p=0.02), whereas DST did not. The proportion of feeding volume taken during the initial 5 min, an index of infants’ actual feeding ability when fatigue is minimal, increased earlier in the DST+OSMS than in the DST.ConclusionsIn very preterm infants, DST+OSMS led to the accelerated attainment of IOF compared with non-intervention, whereas DST alone did not. The effect of DST+OSMS on oral feeding ability appeared earlier than that of DST alone.Trial registration numberClinicalTrials.gov Registry (NCT02508571).

scholarly journals Tube Feeding Practices and Transition to Breastfeeding Experiences of Mothers of Preterm Infants at a Kangaroo Mother Care Unit of a Tertiary Hospital in South Africa

2021 ◽  
Vol 8 ◽  
pp. 2333794X2110370
Author(s):  
Sphiwe Madiba ◽  
Malmsey Sengane
Keyword(s):  
South Africa ◽  
Breast Milk ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Tube Feeding ◽  
Feeding Practices ◽  
Tertiary Hospital ◽  
Very Preterm Infants ◽  
Mothers Of Preterm Infants ◽  
Group Interviews

To receive human milk, most preterm infants initially receive the mothers’ expressed milk through a nasogastric tube. However, breast milk feeding the preterm infant and making the transition to direct breast-feeding come with significant challenges. The study explored and described the experiences of mothers of preterm infants regarding initiation and expressing breast milk, tube feeding practices, and transition to breastfeeding during the infants’ stay in a kangaroo care unit (KMC) of an academic hospital in South Africa. Using a qualitative design, focus group interviews were conducted with 38 mothers of preterm infants after discharge from the neonatal intensive care unit (NICU). We analyzed transcripts following the 5 steps for qualitative thematic data analysis. Tube feeding and breastfeeding preterm infants was challenging and exhausting for the mothers. Many described their experiences of initiating expression and sustaining milk supply as negative. They had constant concerns about their ability to produce adequate milk volumes to feed their infants. They had immense dislike of expressing, which they described as physically exhausting, stressful, and painful. Those who had initiated breastfeeding were highly motivated to breastfeed their preterm infants. They described breastfeeding as a positive bonding experience that they derived pleasure from. The mothers’ dislike of expressing was overshadowed by their emotional obligation toward their preterm infants. Although the KMC unit promotes breastfeeding, mothers encountered problems and struggled to initiate expression and sustain milk production. Mothers of extreme and very preterm infants need support to continue with milk expression during the long NICU and KMC stay.

scholarly journals Availability of Donor Milk for Very Preterm Infants Decreased the Risk of Necrotizing Enterocolitis without Adversely Impacting Growth or Rates of Breastfeeding

Nutrients ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1895 ◽  
Author(s):  
Débora Cañizo Vázquez ◽  
Sandra Salas García ◽  
Montserrat Izquierdo Renau ◽  
Isabel Iglesias-Platas
Keyword(s):  
Preterm Infants ◽  
Necrotizing Enterocolitis ◽  
Neonatal Intensive Care ◽  
Late Onset ◽  
Donor Milk ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Breastfeeding Rates ◽  
Group 2 ◽  
Group 1

Human milk contains non-nutritional factors that promote intestinal maturation and protect against infectious and inflammatory conditions. In the Neonatal Intensive Care Unit (NICU) setting, donor milk (DM) is recommended when availability of own mother’s milk (OMM) is not enough. Our aim was to compare the incidence of necrotizing enterocolitis (NEC) and late-onset sepsis (LOS) in very preterm infants (VPI) after the introduction of DM. Growth and breastfeeding rates were examined as secondary outcomes. Single center, observational and retrospective cohort study comparing 227 VPI admitted to our neonatal unit before (Group 1, n = 99) and after (Group 2, n = 128) DM introduction. Enteral nutrition was started earlier after DM availability (2.6 ± 1.1 vs. 2.1 ± 1 days, p = 0.001). Incidence of NEC decreased in group 2 (9.1% vs. 3.4%, p = 0.055), especially in those born between 28 and 32 weeks (5.4 vs. 0.0%, p = 0.044). Surgical NEC was also less frequent. Suffering NEC was 4 times more likely in group 1 (multivariate analysis). Availability of DM did not impact breastfeeding rates or preterm growth. Our findings support the protective role of DM against NEC, particularly in non-extreme VPI, a group less frequently included in clinical guidelines and research studies on the use of DM.

scholarly journals Cost-effectiveness of strategies preventing late-onset infection in preterm infants

2019 ◽  
Vol 105 (5) ◽  
pp. 452-457
Author(s):  
Alessandro Grosso ◽  
Rita Isabel Neves de Faria ◽  
Laura Bojke ◽  
Chloe Donohue ◽  
Caroline Isabel Fraser ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Life Expectancy ◽  
Preterm Infants ◽  
Healthcare Costs ◽  
Neonatal Intensive Care ◽  
Late Onset ◽  
Controlled Trial ◽  
Cost Effective ◽  
Life Years ◽  
Late Onset Infection

ObjectiveDeveloping a model to analyse the cost-effectiveness of interventions preventing late-onset infection (LOI) in preterm infants and applying it to the evaluation of anti-microbial impregnated peripherally inserted central catheters (AM-PICCs) compared with standard PICCs (S-PICCs).DesignModel-based cost-effectiveness analysis, using data from the Preventing infection using Antimicrobial Impregnated Long Lines (PREVAIL) randomised controlled trial linked to routine healthcare data, supplemented with published literature. The model assumes that LOI increases the risk of neurodevelopmental impairment (NDI).SettingNeonatal intensive care units in the UK National Health Service (NHS).PatientsInfants born ≤32 weeks gestational age, requiring a 1 French gauge PICC.InterventionsAM-PICC and S-PICC.Main outcome measuresLife expectancy, quality-adjusted life years (QALYs) and healthcare costs over the infants’ expected lifetime.ResultsSevere NDI reduces life expectancy by 14.79 (95% CI 4.43 to 26.68; undiscounted) years, 10.63 (95% CI 7.74 to 14.02; discounted) QALYs and costs £19 057 (95% CI £14 197; £24697; discounted) to the NHS. If LOI causes NDI, the maximum acquisition price of an intervention reducing LOI risk by 5% is £120. AM-PICCs increase costs (£54.85 (95% CI £25.95 to £89.12)) but have negligible impact on health outcomes (−0.01 (95% CI −0.09 to 0.04) QALYs), compared with S-PICCs. The NHS can invest up to £2.4 million in research to confirm that AM-PICCs are not cost-effective.ConclusionsThe model quantifies health losses and additional healthcare costs caused by NDI and LOI during neonatal care. Given these consequences, interventions preventing LOI, even by a small extent, can be cost-effective. AM-PICCs, being less effective and more costly than S-PICC, are not likely to be cost-effective.Trial registration numberNCT03260517.

Probiotic Effects on Late-onset Sepsis in Very Preterm Infants: A Randomized Controlled Trial

PEDIATRICS ◽  
2013 ◽  
Vol 132 (6) ◽  
pp. 1055-1062 ◽  
Author(s):  
S. E. Jacobs ◽  
J. M. Tobin ◽  
G. F. Opie ◽  
S. Donath ◽  
S. N. Tabrizi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Infants ◽  
Late Onset ◽  
Controlled Trial ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomized Controlled ◽  
Late Onset Sepsis

scholarly journals Preventive Intervention Program on the Outcomes of Very Preterm Infants and Caregivers: A Multicenter Randomized Controlled Trial

2021 ◽  
Vol 11 (5) ◽  
pp. 575
Author(s):  
Young-Ah Youn ◽  
Seung-Han Shin ◽  
Ee-Kyung Kim ◽  
Hye-Jeong Jin ◽  
Young-Hwa Jung ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Infants ◽  
Intervention Program ◽  
Preventive Intervention ◽  
Controlled Trial ◽  
Neurodevelopmental Outcomes ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Increased survival in the very preterm population results in a higher risk of developing neurodevelopmental and behavioral disabilities among survivors. We examined the outcomes of very preterm infants and parents after a preventive intervention program of four home visits by a specialized nurse, 5 days, 2 weeks, and 1 month after discharge, respectively, and at CA 2 months, followed by up to 12 times of group sessions between CA 3 and 6 months. Our multicenter randomized controlled trial assessed 138 preterm infants (gestational age ≤30 weeks or birth weight ≤1500 g) enrolled from the three participating hospitals. We randomly allocated the preterm babies to either the intervention or the control group. The primary outcome was the neurodevelopmental outcomes of Bayley-III scores at CA 10 and 24 months. At CA 10 months and 24 months, there were no significant differences between the intervention and control groups in the cognitive, motor, and language domains of Bayley-III scores. In addition, there were no significant differences in the mother’s depression scale, mother–child attachment, and the modified Infant and Toddler Social and Emotional Assessment.

scholarly journals Early versus later initiation of parenteral nutrition for very preterm infants: a propensity score-matched observational study

2021 ◽  
pp. fetalneonatal-2021-322383
Author(s):  
Sabita Uthaya ◽  
Nicholas Longford ◽  
Cheryl Battersby ◽  
Kayleigh Oughham ◽  
Julia Lanoue ◽  
...  
Keyword(s):  
Parenteral Nutrition ◽  
Preterm Infants ◽  
Late Onset ◽  
Controlled Trial ◽  
Absolute Difference ◽  
Research Database ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomised Controlled ◽  
The Impact

ObjectiveTo evaluate the impact of timing of initiation of parenteral nutrition (PN) after birth in very preterm infants.DesignPropensity-matched analysis of data from the UK National Neonatal Research Database.Patients65 033 babies <31 weeks gestation admitted to neonatal units in England and Wales between 2008 and 2019.InterventionsPN initiated in the first 2 days (early) versus after the second postnatal day (late). Babies who died in the first 2 days without receiving PN were analysed as ‘late’.Main outcome measuresThe main outcome measure was morbidity-free survival to discharge. The secondary outcomes were survival to discharge, growth and other core neonatal outcomes.FindingsNo difference was found in the primary outcome (absolute rate difference (ARD) between early and late 0.50%, 95% CI −0.45 to 1.45, p=0.29). The early group had higher rates of survival to discharge (ARD 3.3%, 95% CI 2.7 to 3.8, p<0.001), late-onset sepsis (ARD 0.84%, 95% CI 0.48 to 1.2, p<0.001), bronchopulmonary dysplasia (ARD 1.24%, 95% CI 0.30 to 2.17, p=0.01), treated retinopathy of prematurity (ARD 0.50%, 95% CI 0.17 to 0.84, p<0.001), surgical procedures (ARD 0.80%, 95% CI 0.20 to 1.40, p=0.01) and greater drop in weight z-score between birth and discharge (absolute difference 0.019, 95% CI 0.003 to 0.035, p=0.02). Of 4.9% of babies who died in the first 2 days, 3.4% were in the late group and not exposed to PN.ConclusionsResidual confounding and survival bias cannot be excluded and justify the need for a randomised controlled trial powered to detect differences in important functional outcomes.

scholarly journals Feasibility of a guided participation discharge program for very preterm infants in a neonatal intensive care unit: a randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
S. Y. Lee ◽  
J. P. C. Chau ◽  
K. C. Choi ◽  
S. H. S. Lo
Keyword(s):  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Phone Call ◽  
Control Group ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Guided Participation

Abstract Background Previous studies showed that parents of very preterm infants expressed feelings of incompetence and experienced high levels of stress upon the discharge of their infants. We conducted a systematic review of seven studies and observed potential benefits for parental outcomes when using discharge interventions that adopted guided participation (GP). More evidence is needed on the effective doses of discharge interventions underpinned by the principles of GP. Aim To investigate the feasibility and preliminarily estimate the effects on parental competence and stress outcomes of a newly developed, nurse-led, GP discharge program for mothers of very preterm infants. Methods A two-arm randomized controlled trial was conducted in a neonatal intensive care unit (NICU). Mothers of infants with gestational ages of ≤32 weeks who had no congenital malformations and did not need to undergo major surgeries were recruited. All mothers were the primary caregivers to their infants. The intervention group received a nurse-led GP discharge intervention (three structured 30- to 60-min GP sessions and one follow-up phone call). The control group received usual care. The parental outcomes were measured using the Parenting Sense of Competence Scale (C-PSOC) and Perceived Stress Scale (C-PSS) at baseline (T0), on the day of discharge (T1), after the follow-up phone call (within 72 h after discharge) (T2), and 1 month after discharge (T3). The outcomes were analyzed using generalized estimating equations based on intention-to-treat principles. Results Thirty infant–mother dyads were recruited. Greater improvements in the C-PSOC score were observed in the intervention group than in the control group at T1 and T2, although these differences were statistically insignificant. The intervention group exhibited greater improvements than the control group in the C-PSS scores at T1, T2, and T3, although these differences were also not statistically significant. Conclusions The findings suggest that a GP discharge intervention could improve parenting competence and stress among mothers with very preterm infants. The absence of adverse events suggests that the GP discharge intervention could be feasibly implemented in NICU settings. This feasibility study was not powered to determine the effectiveness of the intervention but is anticipated to lay the foundation for a future full-scale study. Trial registration ClinicalTrials.gov Identifier: NCT03668912. Date of registration: 13 September 2018 (retrospectively registered).

Treatment thresholds for intervention in posthaemorrhagic ventricular dilation: a randomised controlled trial

2018 ◽  
Vol 104 (1) ◽  
pp. F70-F75 ◽  
Author(s):  
Linda S de Vries ◽  
Floris Groenendaal ◽  
Kian D Liem ◽  
Axel Heep ◽  
Annemieke J Brouwer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Ventricular Dilatation ◽  
Shunt Revision ◽  
Neurodevelopmental Outcomes ◽  
Vp Shunt ◽  
Significant Difference ◽  
Randomised Controlled

ObjectiveTo compare a low versus a higher threshold for intervention in preterm infants with posthaemorrhagic ventricular dilatation.DesignMulticentre randomised controlled trial (ISRCTN43171322).Setting14 neonatal intensive care units in six countries.Patients126 preterm infants ≤34 weeks gestation with ventricular dilatation after grade III–IV haemorrhage were randomised to low threshold (LT) (ventricular index (VI) >p97 and anterior horn width (AHW) >6 mm) or higher threshold (HT) (VI>p97+4 mm and AHW >10 mm).InterventionCerebrospinal fluid tapping by lumbar punctures (LPs) (max 3), followed by taps from a ventricular reservoir, to reduce VI, and eventually a ventriculoperitoneal (VP) shunt if stabilisation of the VI below the p97+4 mm did not occur.Composite main outcome measureVP shunt or death.Results19 of 64 (30%) LT infants and 23 of 62 (37%) HT infants were shunted or died (P=0.45). A VP shunt was inserted in 12/64 (19%) in the LT and 14/62 (23%) infants in the HT group. 7/12 (58%) LT infants and 1/14 (7%) HT infants required shunt revision (P<0.01). 62 of 64 (97%) LT infants and 36 of 62 (58%) HT infants had LPs (P<0.001). Reservoirs were inserted in 40 of 64 (62%) LT infants and 27 of 62 (43%) HT infants (P<0.05).ConclusionsThere was no significant difference in the primary composite outcome of VP shunt placement or death in infants with posthaemorrhagic ventricular dilatation who were treated at a lower versus a higher threshold for intervention. Infants treated at the lower threshold received more invasive procedures. Assessment of neurodevelopmental outcomes will provide further important information in assessing the risks and benefits of the two treatment approaches.

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