An Analgesic Technique for Orogastric Tube Insertion in Newborns: DOLATSONG, a Randomized Multicentric Controlled Trial.

BACKGROUND: Gastric tube insertion is necessary to support early enteral feeding of newborns during their neonatal intensive care stay. This frequent and invasive procedure is known to be painful. Very few analgesic techniques (sweet solutions, sucking, swaddling, and skin-to-skin contact) are available to reduce the pain caused by orogastric tube insertion procedure. OBJECTIVE: To determine whether a new orogastric tube insertion technique modifies the pain response in newborns, we hypothesize that inserting an orogastric tube through the nipple of a bottle reduces pain caused by this procedure. DESIGN: Prospective, controlled, randomized, multicentered and open label study. SETTINGS: Three neonatal intensive care units in France (2 level 3 units and 1 level 2B). PARTICIPANTS: Full-term or premature newborns at 32 weeks of gestation or more, postnatal age between 48 hours and 21 days, not ventilated and requiring enteral feeding, were randomized into 2 groups: usual technique (n = 36) and experimental technique (n = 35). METHODS: Our experimental technique was to insert the orogastric tube through a modified nipple of a bottle. This method was compared with the usual technique of inserting the tube directly into the newborn's mouth without a support to guide it accompanied by a nipple encouraging sucking with a nonnutritive solution. An association of nonnutritive sucking and orally administered 30% glucose was given to all children for analgesic purposes. Pain during the orogastric tube insertion was assessed on video recordings by 2 independent experts, using a heteroassessment behavioral scale for pain (DAN-Douleur Aiguë du Nouveau-né; APN-Acute Pain in Newborns). The primary outcome was an Acute Pain in Newborns score of less than 3 at the time of the procedure. Comparisons were made using Fisher exact test or Mann-Whitney U test. Factors associated with an Acute Pain in Newborns score of 3 and greater were explored using univariable and multivariable regression models. RESULTS: All but 1 video recording in each group were analyzed. Among the 34 neonates in the experimental group, 71.4% (95% CI: [53.7-85.4]) had an Acute Pain in Newborns score of less than 3 during orogastric tube insertion versus 41% (95% CI: [27.9-61.9]) in the control group (P = .031). Gagging was frequent and nonsignificantly different between the 2 groups (69% in the control group, 51% in the experimental group, P = .13). In multivariable analysis, the experimental technique was an independent factor of pain prevention compared with the usual technique (odds ratio = 0.21 [0.06-0.71], P = .015). CONCLUSIONS: This study suggests that a simple, inexpensive, and feasible technique of orogastric tube insertion through the nipple of a bottle limits pain associated with this procedure in newborns.

Implementation of neonatal phototherapy with the BiliCocoon Bag® device in the maternity ward and impact on mother-infant separation.

BACKGROUND: Free bilirubin jaundice is a frequent pathology in the neonatal period. The major complication is neurological toxicity, the most severe form of which is kernicterus. Overall, 5%-10% of jaundiced neonates require treatment. The first-line treatment is phototherapy, with intensive phototherapy being the gold standard. Other equipment is also available, including the BiliCocoon Bag®. It is a safe and controlled therapy that can be performed in the mother's room in the maternity ward, thereby avoiding separation and allowing for breast- or bottle-feeding during treatment. It is easy to install and does not require protective glasses, thus no scope or hospitalization. In our maternity ward, all neonates requiring intensive phototherapy are hospitalized in the neonatology ward. OBJECTIVE: The objective of our study was to evaluate the number of avoided hospitalizations in neonatology for free bilirubin jaundice since the introduction, according to a strict protocol, of the BiliCocoon Bag® device. MATERIAL AND METHOD: This was a single-center retrospective cohort study using data of newborns usually collected as part of standard care. Children born in our maternity ward during an 18-month period (August 1, 2020 to January 31, 2022) were included. Causes of jaundice, age at the beginning and mode of treatment, number of sessions for each device, and length of stay were compared. Results are presented as number and percentage with median (25th-75th) or mean (extremes) values for categorical and continuous variables, respectively. A t-test was used to compare the means of the independent groups. RESULTS: A total of 316 newborns were included. Physiological jaundice was the main cause of jaundice. The median age for the first phototherapy treatment was 54.5 h (30-68). The 316 neonates needed 438 phototherapy sessions: 235 (74%) neonates required only one phototherapy session, 85 (36%) of them were treated with the BiliCocoon Bag®. For the 81 children who needed two or more phototherapy sessions, 19 children (23.5%) were treated by tunnel phototherapy and then the BiliCocoon Bag®, and eight children (10%) by BiliCocoon Bag® alone. The BiliCocoon Bag® enabled a relative reduction in the hospitalization rate of 38% and avoided hospitalization for approximately one third of the newborns treated. The BiliCocoon Bag® failure rate was 3.6% and the average length of stay was comparable between the two types of treatment. CONCLUSION: Following a strict protocol of use, the BiliCocoon Bag® is a reliable method and a good alternative to intensive phototherapy for newborns in the maternity ward, as it avoids hospitalization and mother-infant separation.

Premedication before laryngoscopy in neonates: Evidence-based statement from the French society of neonatology (SFN).

Context: Laryngoscopy is frequently required in neonatal intensive care. Awake laryngoscopy has deleterious effects but practice remains heterogeneous regarding premedication use. The goal of this statement was to provide evidence-based good practice guidance for clinicians regarding premedication before tracheal intubation, less invasive surfactant administration (LISA) and laryngeal mask insertion in neonates. Methods: A group of experts brought together by the French Society of Neonatology (SFN) addressed 4 fields related to premedication before upper airway access in neonates: (1) tracheal intubation; (2) less invasive surfactant administration; (3) laryngeal mask insertion; (4) use of atropine for the 3 previous procedures. Evidence was gathered and assessed on predefined questions related to these fields. Consensual statements were issued using the GRADE methodology. Results: Among the 15 formalized good practice statements, 2 were strong recommendations to do (Grade 1+) or not to do (Grade 1-), and 4 were discretionary recommendations to do (Grade 2+). For 9 good practice statements, the GRADE method could not be applied, resulting in an expert opinion. For tracheal intubation premedication was considered mandatory except for life-threatening situations (Grade 1+). Recommended premedications were a combination of opioid + muscle blocker (Grade 2+) or propofol in the absence of hemodynamic compromise or hypotension (Grade 2+) while the use of a sole opioid was discouraged (Grade 1-). Statements regarding other molecules before tracheal intubation were expert opinions. For LISA premedication was recommended (Grade 2+) with the use of propofol (Grade 2+). Statements regarding other molecules before LISA were expert opinions. For laryngeal mask insertion and atropine use, no specific data was found and expert opinions were provided. Conclusion: This statement should help clinical decision regarding premedication before neonatal upper airway access and favor standardization of practices.

Premedication practices for neonatal tracheal intubation: Results from the EPIPPAIN 2 prospective cohort study and comparison with EPIPPAIN 1.

To describe the frequency and nature of premedication practices for neonatal tracheal intubation (TI) in 2011; to identify independent risk factors for the absence of premedication; to compare data with those from 2005 and to confront observed practices with current recommendations. Data concerning TI performed in neonates during the first 14 days of their admission to participating neonatal/pediatric intensive care units were prospectively collected at the bedside. This study was part of the Epidemiology of Procedural Pain in Neonates study (EPIPPAIN 2) conducted in 16 tertiary care units in the region of Paris, France, in 2011. Multivariate analysis was used to identify factors associated with premedication use and multilevel analysis to identify center effect. Results were compared with those of the EPIPPAIN 1 study, conducted in 2005 with a similar design, and to a current guidance for the clinician for this procedure. One hundred and twenty-one intubations carried out in 121 patients were analyzed. The specific premedication rate was 47% and drugs used included mainly propofol (26%), sufentanil (24%), and ketamine (12%). Three factors were associated with the use of a specific premedication: nonemergent TI (Odds ratio (OR) [95% CI]: 5.3 [1.49-20.80]), existence of a specific written protocol in the ward (OR [95% CI]:4.80 [2.12-11.57]), and the absence of a nonspecific concurrent analgesia infusion before TI (OR [95% CI]: 3.41 [1.46-8.45]). No center effect was observed. The specific premedication rate was lower than the 56% rate observed in 2005. The drugs used were more homogenous and consistent with the current recommendations than in 2005, especially in centers with a specific written protocol. Premedication use prior to neonatal TI was low, even for nonemergent procedures. Scientific consensus, implementation of international or national recommendations, and local written protocols are urgently needed to improve premedication practices for neonatal intubation.

Premedication practices for delivery room intubations in premature infants in France: Results from the EPIPAGE 2 cohort study.

OBJECTIVES: To assess premedication practices before tracheal intubation of premature newborns in the delivery room (DR). STUDY DESIGN: From the national population-based prospective EPIPAGE 2 cohort in 2011, we extracted all live born preterms intubated in the DR in level-3 centers, without subsequent circulatory resuscitation. Studied outcomes included the rate and type of premedication, infants' and maternities' characteristics and survival and major neonatal morbidities at discharge from hospital. Univariate and multivariate analysis were performed and a generalized estimating equation was used to identify factors associated with premedication use. RESULTS: Out of 1494 included neonates born in 65 maternities, 76 (5.1%) received a premedication. Midazolam was the most used drug accounting for 49% of the nine drugs regimens observed. Premedicated, as compared to non premedicated neonates, had a higher median [IQR] gestational age (30 [28-31] vs 28 [27-30] weeks, p<10-3), median birth weight (1391 [1037-1767] vs 1074 [840-1440] g, p<10-3) and median 1-minute Apgar score (8 [6-9] vs 6 [3-8], p<10-3). Using univariate analyses, premedication was significantly less frequent after maternal general anesthesia and during nighttime and survival without major morbidity was significantly higher among premedicated neonates (56/73 (81.4%) vs 870/1341 (69.3%), p = 0.028). Only 10 centers used premedication at least once and had characteristics comparable to the 55 other centers. In these 10 centers, premedication rates varied from 2% to 75%, and multivariate analysis identified gestational age and 1-minute Apgar score as independent factors associated with premedication use. CONCLUSION: Premedication rate before tracheal intubation was only 5.1% in the DR of level-3 maternities for premature neonates below 34 weeks of gestation in France in 2011 and seemed to be mainly associated with centers' local policies.

Neonatal Pain, Still Searching for the Optimal Approach.

BACKGROUND: although neonatal pain management has seen huge improvements in the past years, many gaps between knowledge and practice still exist. OBJECTIVE: to give the reader the state of the art of actual pain management and treatment. METHODS: a literature review was done on the physiopathology of pain, sex differences in the perception of pain, epidemiology, non-pharmacological treatment and developmental care approach, pharmacological treatment with pharmacokinetics and pharmacodynamics approaches. CONCLUSION: despite an increasing knowledge in the field of neonatal pain, many gaps and questions remain, especially relative to the lack of assessment, prevention and treatment of painful procedures, appropriate drugs and dosing to support the well-being and the brain development of this highly vulnerable population.

Congenital cytomegalovirus infection manifesting as neonatal persistent pulmonary hypertension: report of two cases.

UNLABELLED: Various neonatal symptoms can lead to a diagnosis of congenital CMV infection. We report two cases of persistent pulmonary hypertension in relation with congenital CMV infection following maternal primary infection and reinfection, respectively. Both infants had severe refractory hypoxemia, requiring high-frequency ventilation, inhaled nitric oxide and inotropic support. One of them required extracorporeal membrane oxygenation for five days. Ganciclovir therapy was attempted in the two cases on day 12 postnatal. One of the infant died on day 15 postnatal. The other survived and is developing uneventfully at 15 months of age. CONCLUSION: Neonatal persistent pulmonary hypertension can be the consequence of congenital CMV infection. Intensive respiratory support and IV ganciclovir are indicated in case of life-threatening condition.

Analgesic effects of EMLA cream and oral sucrose during venipuncture in preterm infants.

OBJECTIVE: The goal of this study was to compare the analgesic effect of sucrose with that of the combination of sucrose and the local anesthetic cream EMLA during venipuncture in preterm neonates. METHODS: This randomized, double-blind prospective study included infants younger than 37 weeks' gestational age during 1 routine venipuncture for blood sampling. Each child randomly received either sucrose plus application of a placebo cream (S group) or sucrose plus EMLA cream (S+E group) before venipuncture. Venipuncture-induced pain was assessed through videotapes of the procedures by using the Douleur Aiguë Nouveau-né (DAN) behavioral scale. Pain was assessed at 2 phases: during venipuncture (from needle introduction to its removal) and during the recovery period (30 seconds after needle removal). Pain scores over time and between treatments were compared by using repeated-measures analysis of variance. RESULTS: The study included 76 children (37 in the S group, 39 in the S+E group). Mean (SD) DAN pain scores for the S group and the S+E group were 7.7 (2.1) and 6.4 (2.5), respectively, during venipuncture and 7.1 (2.8) and 5.7 (3.3) during the postinjection period. A significant time and treatment effect in favor of the S+E group was observed. CONCLUSION: The combination of sucrose and EMLA cream revealed a higher analgesic effect than sucrose alone during venipuncture in these preterm infants.

Pain management in newborns: from prevention to treatment.

All neonates in the Neonatal Intensive Care Unit (NICU) or during the first days of life undergo painful and stressful procedures. Epidemiologic studies have shown that pain induced by these procedures is not effectively prevented or is inadequately treated. Pain experienced during the neonatal period may lead to negative outcomes, especially in preterm neonates. Prevention is the first step of pain management, and practical guidelines should be used in the NICU. Assessment must be done with adequate tools that take into account the infant's pathology and gestational age. Distinguishing between acute and prolonged pain is important for both assessment and treatment. The most common drugs that have been studied for the treatment of pain and stress are opioids, hypnosedatives, and NMDA receptor antagonists. Morphine and fentanyl are most frequently used for acute or prolonged pain in the NICU. They have potent analgesic effects and few immediate or long-term adverse effects. Midazolam is a commonly used hypnosedative, but its adverse effects limit its use. Drugs such as propofol and ketamine have been used for acute painful procedures; however, further research is needed to assess their long-term effects. Use of non-pharmacologic pain management techniques has increased in recent years. These methods are easy, inexpensive, and effective in helping newborns recover from painful procedures. Sweet solutions and non-nutritive sucking, breastfeeding, skin-to-skin mother care, swaddling, and facilitated tucking are the most commonly employed and evaluated non-pharmacologic methods. Hospitals should promote and improve parent involvement in pain management. In-service education and well organized hospital teams are crucial for successful implementation of pain protocols in newborns.

Neonatal care in patients with giant ompholocele: arduous management but favorable outcomes.

OBJECTIVES: The objectives of the study were to provide a review of patients with giant omphalocele managed in a single institution (2001-2006), focusing on medical management in the neonatal period, and to evaluate short-term outcomes. METHODS: Data from 14 neonates with giant ompholocele (abdominal wall defect >5 cm and/or containing liver) and the absence of malformation and chromosomal anomalies during fetal screening were retrospectively reviewed. All were intubated and sedated before surgical treatment. Initial management consisted of progressive reduction of the herniated organs by gentle compression. After sequential reduction, abdominal wall closure was attempted at the skin and fascia level and, when necessary, with a Gore-Tex patch. RESULTS: Median gestational age was 39 weeks (38-40), and median birth weight was 3100 g (2470-3700). Median age at closure was 6 days (0-20). A central Gore-Tex patch was inserted in 10 cases. Median ventilation length was 26 days (2-78). Full enteral diet was achieved after an average of 33 days (8-82), and median time until discharge from the intensive care unit was 24.5 days (11-85). Nine patients developed sepsis in the postoperative course. In 10 patients, at least 1 associated malformation was diagnosed in the postnatal course, among which cardiac and diaphragmatic defects were the most common. Survival rate was 85.7%. CONCLUSION: Mortality rate of giant omphalocele without chromosomal anomaly or major malformations is low when treated by gradual reduction of the contents. Parents should be informed of the long hospitalization in the intensive care unit at birth, the potential nonthreatening associated malformations to be diagnosed after birth, and the high risk of sepsis.

Neonatal outcome of gastroschisis is mainly influenced by nutritional management.

OBJECTIVE: The aim of the study was to evaluate early minimal enteral feeding (MEF) and gradual enteral nutrition increment on neonatal outcome of gastroschisis. PATIENTS AND METHODS: An intervention group was prospectively assessed and compared with an observational historical control group. The prospective study relied on a new protocol of enteral nutrition. According to the new protocol, MEF was initiated 5 days after bowel reintegration and milk amounts were increased 12 mL/kg/day. In the control group, enteral nutrition was delayed until resolution of postoperative ileus, and increment of feeding was not systematized. RESULTS: Twenty-two patients were included in the MEF group and compared with 51 control patients. Infants in the control group had lower gestational age (36 vs 35 gestational weeks [GW], P=0.03) and birth weight (2465 vs 2200 g, P=0.05). Time to first enteral nutrition (5 vs 11.5 days, P=0.0005) was significantly shorter in the MEF group. All patients in this group were fully enteral fed at day 60, though 30.4% of patients in the control group still needed parenteral nutrition at day 60 (P=0.004). Incidence of nosocomial infection was reduced (9% of patients vs 40%, P=0.016) and hospital stay tended to be shorter in the MEF group (40 vs 54.5 days, P=0.08). In the univariate analysis, factors influencing the length of parenteral nutrition during the 2 periods were the severity of perivisceritis and new nutritional protocol. In the multivariate analysis, only nutritional protocol was significantly associated with the length of parenteral nutrition (P=0.038). CONCLUSIONS: Early MEF and controlled increase of nutritional elements after bowel reintegration significantly improved outcome of gastroschisis in newborns.

Experience in the management of eighty-two newborns with congenital diaphragmatic hernia treated with high-frequency oscillatory ventilation and delayed surgery without the use of extracorporeal membrane oxygenation.

The aim of this study is to analyze neonatal outcome of isolated congenital diaphragmatic hernia and to identify prenatal and postnatal prognosis-related factors. A retrospective single institution series from January 2000 to November 2005 of isolated congenital diaphragmatic hernia neonates was reviewed. Respiratory-care strategy was early high-frequency oscillatory ventilation, nitric oxide in pulmonary hypertension, and delayed surgery after respiratory and hemodynamic stabilization. Survival rate at 1 month was 65.9%. None of the prenatal factors were predictive of neonatal outcome, except an intra-abdominal stomach in left diaphragmatic hernia. Preoperative pulmonary hypertension was more severe in the nonsurvivor group and was predictive of length of ventilation in the survivors. During the first 48 hours of life, the best oxygenation index above 13 and the best PaCO2 above 45 were predictive of poor outcome. When treating isolated congenital diaphragmatic hernia with early high-frequency ventilation and delayed surgery but excluding extracorporeal membrane oxygenation, survival rates compare favorably with other reported series, and the respiratory morbidity is low.

Prenatal prognosis in isolated congenital diaphragmatic hernia.

OBJECTIVE: A monocentric retrospective study of 79 neonates with isolated diaphragmatic hernia antenatally diagnosed was performed to identify prenatal parameters that may characterize the severity of the disease. STUDY DESIGN: Postnatal treatment protocol included early high frequency ventilation, inhaled nitric oxide, and delayed surgery. Postnatal survival rate was 63.3%. RESULTS: Age at diagnosis, polyhydramnios, and left ventricle/right ventricle index were not related with survival. None of the 9 left diaphragmatic hernias with intraabdominal stomach died. Neonatal mortality was significantly related with the side of the defect, intrathoracic position of the liver, the ratio of fetal lung area to head circumference value, and fetal lung volume ratio measured by resonance magnetic imaging. CONCLUSION: No prenatal factor alone firmly predicts neonatal outcome. Clinicians should help stratify the severity of the disease and compare accurately different postnatal therapeutic strategies.