ABSTRACT
Importance: Delayed meconium evacuation and delayed achievement of full enteral feeding among premature infants are associated with poor short- and long-term outcomes. Identifying a more effective and safer enema for meconium evacuation is imperative for improving neonatal care. Objective: To examine whether breast milk enemas can shorten the time to complete meconium evacuation and achievement of full enteral feeding for preterm infants. Design, Setting, and Participants: This randomized, open-label, parallel-group, single-center clinical trial was conducted from September 1, 2019, to September 30, 2022, among 286 preterm infants with a gestational age of 23 to 30 weeks in the neonatal ward of the Shengjing Hospital of China Medical University in Shenyang. Interventions: Preterm infants were randomly assigned to receive either breast milk enemas or normal saline enemas 48 hours after birth. Main Outcome and Measures: The primary outcomes were time to complete meconium evacuation and time to achieve full enteral feeding. Secondary outcomes were duration of hospitalization, weight at discharge, and duration of total parenteral nutrition. Intention-to-treat and per-protocol analyses were conducted. Results: In total, 286 preterm infants (mean [SD] gestational age, 198.8 [7.9] days; 166 boys [58.0%]) were eligible and included in this study. A total of 145 infants were randomized to the normal saline group, and 141 were randomized to the breast milk group. The time to achieve complete meconium evacuation was significantly shorter in the breast milk group than in the normal saline group (-2.2 days; 95% CI, -3.2 to -1.2 days). The time to achieve full enteral feeding was also significantly shorter in the breast milk group than in the normal saline group (-4.6 days; 95% CI, -8.0 to -1.2 days). The duration of total parenteral nutrition was significantly shorter in the breast milk group than in the normal saline group (-4.6 days; 95% CI, -8.6 to -1.0 days). There were no clinically notable differences in any other secondary or safety outcomes between the 2 groups. Conclusions and Relevance: In this randomized clinical trial testing the effects of breast milk enema on meconium evacuation, breast milk reduced the time to achieve complete meconium evacuation and achieve full enteral feeding for preterm infants with a gestational age of 23 to 30 weeks. Subgroup analyses highlight the need for tailored interventions based on gestational age considerations. Trial Registration: isrctn.org Identifier: ISRCTN17847514.
Subject(s)
Enema , Infant, Premature , Meconium , Milk, Human , Humans , Enema/methods , Infant, Newborn , Female , Male , China , Enteral Nutrition/methods , Gestational AgeABSTRACT
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.
Subject(s)
Meconium , Milk, Human , Enema/adverse effects , Female , Humans , Infant , Infant, Newborn , Infant, Premature , Infant, Very Low Birth Weight , Randomized Controlled Trials as TopicABSTRACT
The optical properties of p-type GaSe and mixed GaSe(1-x)S(x), x=0.04, 0.023, 0.090, 0.133, 0.175, 0.216, 0.256, 0.362, 0.369, and 0.412, crystals were studied to reveal the potentials for phase matching and frequency conversion. Comparative experiment on Er3+:YSGG and CO2 laser SHG at identical experimental conditions is carried out at room temperature. Any change in polytype structure of GaSe1(1-x)S(x) was not found.
Subject(s)
Gallium/chemistry , Lasers , Models, Theoretical , Optics and Photonics/instrumentation , Selenium/chemistry , Computer Simulation , Crystallization/methods , Equipment Design , Equipment Failure Analysis , Light , Scattering, Radiation , TemperatureABSTRACT
Optical transmission range and phase matching (PM) conditions for second harmonic generation (SHG) of Er3+:YSGG and CO2 laser in indium doped GaSe:In(0.1, 1.23, 2.32 mass%) are studied in comparison with these in pure and sulfur doped GaSe:S(0.09, 0.5, 2.2, 3 mass%) crystals. No changes in transparency curve are found in GaSe crystals up to 2.32 mass% indium content, but as small change as 0.18 degrees in PM angle for 2.79 microm Er3+:YSGG laser SHG and approximately 0.06 degrees for 9.58 microm CO2 laser emission line SHG are detected. PM properties of the crystals are evaluated as a function of temperature over the range from -165 to 230 degrees C. The value of dtheta/dT, the change in PM angle with variation of temperature, is found to be very small for GaSe:In crystals. While for SHG of Er3+:YSGG laser, dtheta/dT =22"/1 degrees C only, it is as small as -4.9"/1 degrees C for that of CO2 laser radiation. Linear variation of PM angle with temperature increasing is an indicator of absence of crystals structure transformation within temperature range from -165 to 230 degrees C. Thus, application of GaSe:In solid solutions in high average power nonlinear optical systems seems to be prospective.