Is early breast milk fortification more effective in preterm infants?: a clinical trial

AbstractObjective:Breast feeding alone does not provide adequate nutrition for growth in preterm infants; therefore, fortifiers are added when over 70–80 cc/kg/day of breast milk is tolerated. As there are few studies comparing early and late breast milk fortification, the following study was conducted.Study design:This double-blind clinical trial was performed on 80 preterm infants (gestational age of 28–34 weeks, birth weight <2 kg). The newborns were randomly divided into two groups to receive either early or late fortification. The primary and secondary outcomes were the difference in growth indices and complications (including feeding intolerance, necrotizing enterocolitis (NEC), and septicemia) between the two groups, respectively.Results:Both groups showed increases in growth indices; however, there was no statistically significant difference in increments of growth indices and complications between the two groups.Conclusion:Our findings suggest that early fortification from the first feeding in neonates with exclusive breast feeding did not improve growth in the first 4 weeks in preterm neonates in comparison with late fortification; so early fortification may not be cost effective.

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Growth Pattern of Early and Late Breast Fed Preterm (30-35 Weeks' Gestation) Neonates: A Hospital Based Study

Bangladesh Journal of Child Health ◽

10.3329/bjch.v31i1.6071 ◽

1970 ◽

pp. 26-31

Author(s):

Tahsinul Amin ◽

MAK Azad Chowdhury ◽

M Monir Hossain ◽

M Mahbubul Hoque

Keyword(s):

Breast Milk ◽

Breast Feeding ◽

Enteral Feeding ◽

Growth Pattern ◽

Controlled Trial ◽

Cost Effective ◽

Preterm Neonates ◽

Early Feeding ◽

Breast Fed ◽

Better Than

Background: There is still controversy among the pediatricians regarding when and how to start enteral feeding in preterm neonates. However, early feeding with breast milk was presumed to be well-tolerated, cost-effective and promote growth better than late feeding. Objectives: To compare growth pattern, benefits and risks between early and late breast feeding in preterm (30-35 weeks' gestation) neonates. Methods: This was a randomized controlled trial. Total 100 preterm neonates were stratified into early feeding (n=50) and late feeding (n=50) groups. Early feeding was started on day 3 and late feeding on day 5 of life with expressed breast milk as 20 ml/ kg/day by gavage feeding with daily increment 20 ml/kg till full enteral feeding. Growth was recorded by anthropometric measurements with accuracy and precision for first 3 months of life. Results: Early breast feeding was found to be significantly better than late breast feeding in duration to reach full feeding (13.08 days vs. 16.70 days), time to regain enrolment weight (10.87 days vs. 13.70 days), feed tolerance (78% vs. 58%), hospital stay (13.58 days vs. 16.82 days), mean weight (3773.62 ±310.49 gm vs. 3636.91 ±340.20 gm), linear growth (53.64 ±2.26 cm vs. 52.62 ±2.04 cm) and OFC growth (35.85 ±1.50 cm vs. 35.35 ±1.40 cm) at 3 months of age. Conclusion: Early feeding with breast milk is well tolerated with less morbidity and promotes growth better than late feeding in preterm neonates. Key words: Growth pattern; preterm; breast fed DOI: 10.3329/bjch.v31i1.6071 Bangladesh Journal of Child Health 2007; Vol.31(1-3): 26-31

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The effect of inhaling mother’s breast milk odor on the behavioral responses to pain caused by hepatitis B vaccine in preterm infants: a randomized clinical trial

BMC Pediatrics ◽

10.1186/s12887-021-02519-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Zahra Akbarian Rad ◽

Parvin Aziznejadroshan ◽

Adeleh Saebi Amiri ◽

Hemmat Gholinia Ahangar ◽

Zahra Valizadehchari

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Heart Rate ◽

Breast Milk ◽

Hepatitis B ◽

Randomized Clinical Trial ◽

Preterm Infants ◽

Behavioral Responses ◽

Significant Difference ◽

Hb Vaccine

Abstract Background Nowadays, it is generally assumed that non-pharmacologic pain relief in preterm infants is an important measure to consider. Research findings suggest that familiar odors have soothing effects for neonates. The aim of this study was to compare the effect of maternal breast milk odor (MBMO) with that of another mother’s breast milk odor (BMO) on the behavioral responses to pain caused by hepatitis B (HB) vaccine injection in preterm infants. Methods This single-blind randomized clinical trial was performed over the period between February 2019 and March 2020 in the neonatal intensive care unit of Babol Rouhani Hospital, Iran. Ninety preterm infants, who were supposed to receive their HB vaccine, were randomly assigned into three groups: MBMO (A), another mother’s BMO (B), and control with distilled water(C). Oxygen saturation (SaO2), blood pressure (BP) and heart rate (HR) were recorded for all participants through electronic monitoring. In addition, premature infant pain profiles (PIPP) were determined through video recording for all three groups during intervention. The chi-square, ANOVA and ANCOVA were used for analyzing the data, and P < 0.05 was considered significant in this study. Results No significant differences were found between the three groups in mean ± SD of HR, BP, and Sao2 before the intervention (P > 0.05). After the intervention, however, the means for heart rate in groups A, B, and C were 146 ± 14.3, 153 ± 17.5 and 155 ± 17.7, respectively (P = 0.012). Moreover, the means for PIPP scores in groups A, B and C were 6.6 ± 1.3, 10 ± 2, and 11.4 ± 1.9, respectively (P < 0.001). There was no significant difference found between groups in their means of SaO2, systolic and diastolic blood pressure after the intervention (P > 0.05). Conclusions The results indicate that stimulation with MBMO is effective in reducing pain in preterm infants; therefore, it can be postulated that this technique can be considered in less invasive procedures such as needling. Trial registration IRCT, IRCT20190220042771N1. Registered 18 May 2019- Retrospectively registered,

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The effect of inhaling mother’s breast milk odor on the behavioral responses to pain caused by hepatitis B vaccine in preterm infants: a randomized clinical trial

10.21203/rs.3.rs-45921/v3 ◽

2021 ◽

Author(s):

Zahra Akbarian Rad ◽

Parvin Aziznejadroshan ◽

Adeleh Saebi Amiri ◽

Hemmat Gholinia Ahangar ◽

Zahra Valizadehchari

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Heart Rate ◽

Breast Milk ◽

Hepatitis B ◽

Randomized Clinical Trial ◽

Preterm Infants ◽

Behavioral Responses ◽

Significant Difference ◽

Hb Vaccine

Abstract Background: Nowadays, it is generally assumed that non-pharmacologic pain relief in preterm infants is an important measure to consider. Research findings suggest that familiar odors have soothing effects for neonates. The aim of this study was to compare the effect of maternal breast milk odor (MBMO) with that of another mother’s breast milk odor (BMO) on the behavioral responses to pain caused by hepatitis B (HB) vaccine injection in preterm infants.Methods: This single-blind randomized clinical trial was performed over the period between February 2019 and March 2020 in the neonatal intensive care unit of Babol Rouhani Hospital, Iran. Ninety preterm infants, who were supposed to receive their HB vaccine, were randomly assigned into three groups: MBMO (A), another mother’s BMO (B), and control with distilled water(C). Oxygen saturation (SaO2), blood pressure (BP) and heart rate (HR) were recorded for all participants through electronic monitoring. In addition, premature infant pain profiles (PIPP) were determined through video recording for all three groups during intervention. The chi-square, ANOVA and ANCOVA were used for analyzing the data, and P<0.05 was considered significant in this study.Results: No significant differences were found between the three groups in mean± SD of HR, BP, and Sao2 before the intervention (P>0.05). After the intervention, however, the means for heart rate in groups A, B, and C were 146±14.3, 153±17.5 and 155±17.7, respectively (P=0.012). Moreover, the means for PIPP scores in groups A, B and C were 6.6±1.3, 10 ±2, and 11.4±1.9, respectively (P<0.001). There was no significant difference found between groups in their means of SaO2, systolic and diastolic blood pressure after the intervention (P>0.05). Conclusions: The results indicate that stimulation with MBMO is effective in reducing pain in preterm infants; therefore, it can be postulated that this technique can be considered in less invasive procedures such as needling.Trial registration: IRCT, IRCT20190220042771N1. Registered 18 May 2019- Retrospectively registered, https://en.irct.ir/trial/37646

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The Effect of Inhaling Mother’s Breast Milk Odor on the Behavioral Responses to Pain Caused by Hepatitis B Vaccine in Preterm Infants: A Randomized Clinical Trial

10.21203/rs.3.rs-45921/v1 ◽

2020 ◽

Author(s):

Adeleh Saebi Amiri ◽

parvin aziznejadroshan ◽

Zahra Akbarian Rad ◽

Hemmat gholinia ahangar ◽

Zahra Valizadehchari

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Heart Rate ◽

Breast Milk ◽

Hepatitis B ◽

Randomized Clinical Trial ◽

Preterm Infants ◽

Behavioral Responses ◽

Significant Difference ◽

The Mean

Abstract Background: Pain control in preterm infants is especially important if the necessary measures are not taken in this regard, the evolutionary process of the brain will be disrupted, and the unrelieved pain can have lifelong consequences. The aim of this study was to compare the effect of maternal breast milk odor (MBMO) with that of another mother’s breast milk odor (BMO) on the behavioral responses to pain caused by hepatitis B vaccine (HBV) injection in preterm infants.Methods: This single-blind randomized clinical trial was performed in the neonatal intensive care unit of Babol Rouhani Hospital, Iran from February 2019 to March 2020. Totally, 90 preterm infants who were to receive the HBV for the first time were randomly selected by random sampling. The neonates were randomly assigned into three groups of (A) MBMO (B) another mother’s BMO and (C) control (distilled water).The data were collected using a questionnaire of demographic characteristics and premature infant pain profile (PIPP). Physiological data were recorded by the pulse oximeter immediately before and after the intervention. The data were analyzed using SPSS18 through chi-square, ANOVA and ANCOVA, and P<0.05 was considered as significant level.Results: Before intervention, there was no significant difference between groups in the mean of heart rate, blood pressure and arterial oxygen saturation (SaO2) percentage (P>0.05). After intervention, there was no significant difference between these A, B and C groups in the mean of systolic blood pressure (70.90±8.29, 70.27±6.70 and 71.77±9.07), diastolic blood pressure (43.63±9.59, 41.77±7.10 and 44.03±10.76) and SaO2 percentage (95.20±5.20, 94.00±6.23 and 91.13±11.78), respectively (P>0.05). However, after intervention, there was a significant difference between groups of A, B and C in the mean of heart rate (146. 6±14.3, 153.70±17.5 and 155.70±17.7), respectively (P=0.01). Moreover, the mean PIPP score was 6.6±1.3, 10 ±2 and 11.4±1.9 in groups A, B and C respectively, so that a significant statistical difference was found between groups (P<0.001). Conclusions: Stimulation with MBMO is effective in reducing the pain of preterm infants, so it can be used in less invasive procedures such as vaccination.Trial registration: IRCT, IRCT20190220042771N1. Registered 18 May 2019- Retrospectively registered, https://en.irct.ir/trial/37646

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Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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The Effect of Individualized Developmental Care Practices in Preterm Infants

Complementary Medicine Research ◽

10.1159/000504357 ◽

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.

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Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

The Journal of Laryngology & Otology ◽

10.1017/s0022215100103913 ◽

1988 ◽

Vol 102 (1) ◽

pp. 39-42 ◽

Cited By ~ 5

Author(s):

S. Kristensen ◽

K. Tveteraas ◽

P. Hein ◽

H. B. Poulsen ◽

K. E. Outzen

Keyword(s):

Clinical Trial ◽

Acetylsalicylic Acid ◽

Pain Intensity ◽

Sleep Disturbances ◽

Significant Positive Correlation ◽

Controlled Trial ◽

Double Blind ◽

Treatment Groups ◽

Significant Difference ◽

Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

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Solumedrol Treatment for Severe Sepsis in Humans with a Blunted Adrenocorticotropic Hormone-Cortisol Response: A Prospective Randomized Double-Blind Placebo-Controlled Pilot Clinical Trial

Journal of Intensive Care Medicine ◽

10.1177/08850666211038883 ◽

2021 ◽

pp. 088506662110388

Author(s):

Divya Birudaraju ◽

Sajad Hamal ◽

John A. Tayek

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Adrenocorticotropic Hormone ◽

Serum Cortisol ◽

High Dose ◽

Cortisol Response ◽

Acth Stimulation ◽

Double Blind ◽

Significant Difference ◽

To Receive

Purpose To test the benefits of Solumedrol treatment in sepsis patients with a blunted adrenocorticotropic hormone (ACTH)-cortisol response (delta <13 µg/dL) with regard to the number of days on ventilator, days on intravenous blood pressure support, length of time in an intensive care unit (ICU), 14-day mortality, and 28-day mortality. The trial was prospective, randomized, and double-blind. As part of a larger sepsis trial, 54 patients with sepsis had an intravenous ACTH stimulation test using 250 µg of ACTH, and serum cortisol was measured at times 0, 30, and 60 min. Eleven patients failed to increase their cortisol concentration above 19.9 µg/dL and were excluded from the clinical trial as they were considered to have adrenal insufficiency. The remaining 43 patients had a baseline cortisol of 32 ± 1 µg/dL increased to 38 ± 3 µg/dL at 30 min and 40 ± 3 at 60 min. All cortisol responses were <12.9 µg/dL between time 0 and time 60, which is defined as a blunted cortisol response to intravenous ACTH administration. Twenty-one were randomized to receive 20 mg of intravenous Solumedrol and 22 were randomized to receive a matching placebo every 8 h for 7-days. There was no significant difference between the two randomized groups. Data analysis was carried out bya two-tailed test and P < .05 as significant. Results Results: The mean age was 51 ± 2 (mean ± SEM) with 61% female. Groups were well matched with regard to APACHE III score in Solumedrol versus placebo (59 ± 6 vs 59 ± 6), white blood cell count (18.8 ± 2.2 vs 18.6 ± 2.6), and incidence of bacteremia (29 vs 39%). The 28-day mortality rate was reduced in the Solumedrol treated arm (43 ± 11 vs 73 ± 10%; P < .05). There was no change in days in ICU, days on blood pressure agents, or days on ventilator. Seven days of high-dose intravenous Solumedrol treatment (20 mg every 8 h) in patients with a blunted cortisol response to ACTH was associated with an improved 28-day survival. This small study suggests that an inability to increase endogenous cortisol production in patients with sepsis who are then provided steroid treatment could improve survival.

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Effects of oral stimulation with breast milk in preterm infants oral feeding: a randomized clinical trial

Journal of Perinatal Medicine ◽

10.1515/jpm-2020-0282 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Qiong Le ◽

Sheng-hua Zheng ◽

Lan Zhang ◽

Li-fen Wu ◽

Feng-juan Zhou ◽

...

Keyword(s):

Clinical Trial ◽

Breast Milk ◽

Premature Infant ◽

Preterm Infants ◽

Oral Feeding ◽

Transition Time ◽

Control Group ◽

Oral Motor ◽

Oral Stimulation ◽

Nutritive Sucking

Abstract Objectives This study was performed to evaluate the effect of oral stimulation with breast milk for preterm infants. Methods A total of 68 subjects form neonatal intensive care unit were randomly assigned into control group (n=20), premature infant oral motor intervention (PIOMI) group (n=25) and premature infant oral motor intervention with breast milk (BM-PIOMI) group (n=23). Results BM-PIOMI group had significant shorter initiation of oral feeding (IOF) time compared to PIOMI group (2.95 days, 95% CI [0.42–5.48]) or control group (9.79 days, 95% CI [7.07–12.51]). BM-PIOMI group had significant sooner transition time from IOF to full oral feeding (FOF) compared to control group (6.68 days, 95% CI [2.2–11.16]), but not to PIOMI group (2.09 days, 95% CI [−2.07 to 6.25]). Length of hospital stay (LOS) did not show statistical different between three groups (control 38.85 ± 14.40 vs. PIOMI 38.48 ± 11.76 vs. BM-PIOMI 38.04 ± 12.2). Growth mixture model identified improvement in non-nutritive sucking (NNS) score in BM-PIOMI group compared to control and PIOMI group (0.8293, p<0.0001, and 0.8296, p<0.0001, respectively). Conclusions Oral stimulation with breast milk can better promotes the oral feeding process of premature infants than the simple oral stimulation, by shorten IOF time and improve early NNS score, but does not shorten transition time from IOF to FOF and LOS. Trial registration The trial identification number is ChiCTR1800019134 (Chinese Clinical Trial Registry http://www.who.int/ictrp/network/chictr2/en/)

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Thyroid dysfunction in preterm neonates exposed to iodine

Journal of Perinatal Medicine ◽

10.1515/jpm-2016-0141 ◽

2017 ◽

Vol 45 (1) ◽

Cited By ~ 13

Author(s):

Fiona L.R. Williams ◽

Jennifer Watson ◽

Chris Day ◽

Aung Soe ◽

Sateesh K. Somisetty ◽

...

Keyword(s):

Caesarean Section ◽

Contrast Media ◽

Preterm Infants ◽

Breast Feeding ◽

Thyroid Dysfunction ◽

Exposed Group ◽

Preterm Neonates ◽

Iodinated Contrast Media ◽

Iodinated Contrast ◽

Blood Spot

AbstractBackground:Infants <32 weeks’ gestation should not be exposed to topical iodine and its avoidance is recommended during pregnancy and breast feeding. Exposure to contrast media and topical iodine is frequently used in many preterm neonates.Aim:To determine whether thyrotropin levels in preterm infants are affected by exposure to intrapartum/neonatal topical iodine and/or the use of iodinated contrast media.Design:Infants <32 weeks’ gestation were recruited. Maternal and neonatal exposures to iodinated contrast media and topical iodine were recorded; levels of thyrotropin and thyroxine were measured from blood-spot cards on postnatal days 7, 14, 28 and the equivalent of 36 weeks’ gestation.Results:One hundred and twenty-five infants were exposed to topical iodine/contrast media and 48 infants were unexposed. No infants were treated for hypothyroidism; three infants (exposed group) had transient hyperthyrotropinaemia. Mean thyrotropin levels were significantly higher on postnatal days 7, 14 and 28 in infants exposed to topical iodine prior to caesarean section compared to unexposed infants, a relationship which persisted after adjustment.Conclusions:In the context of this study, neonatal thyroid dysfunction was seen following exposure to iodine via caesarean section but not via exposure to contrast media.

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