Wagh S Amargeet and Jain Naveen / JPBMS, 2012, 15 (9) Available online at Research JPBMS article

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1 Available online at Research JPBMS article ISSN NO CODEN JPBSCT JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL SCIENCES Comparison of neonatal morbidities of late preterm with term born babies. * Amarjeet S Wagh 1 and Naveen Jain 2. 1 Department of Pediatrics & Neonatology, Kerala Institute of Medical Sciences, Trivandrum, Kerala, India. 2 DM, Consultant Neonatologist, Kerala Institute of Medical Sciences, Trivandrum, Kerala, India. Abstract: Objectives: To compare the neonatal morbidities of late preterm babies with babies born term. Methods: Prospective observational study. Settings: Referral NICU Study period: 18 months Results: 114 late preterm babies were compared against 1094 term born babies. Late preterm babies had more neonatal morbidities compared to term babies (85 % vs 16.3 %). Need for resuscitation (14 vs 1.7 %), need for respiratory support (29.8 vs 3.4 %), hypoglycemia (30 vs 2.2 %), hyperbilirubinemia (50 vs 10.4 %), sepsis (9.6 vs 0.9 %), need for intravenous fluids (58 vs 2 %) were more in late preterms as compared to term babies. 94 % term babies were exclusively breast fed at discharge as against only 53.5 % late preterms. 83 (72.8 %) babies were followed up to 3 months age corrected for prematurity. 3.6 % had weights less than 5 th centile and 83 % between 5 50 th. 4.8 % of babies had an abnormal field on DDST and 20.4 % had a questionable test. Babies delivered late preterm for maternal or fetal indications had significantly more risk of neonatal morbidities than those born early due to preterm labor. Use of antenatal steroids did not alter outcomes. Conclusions: late preterm babies have higher risk of neonatal morbidities. They are likely to have growth and development concerns even at 3 months corrected age. Keywords: late preterm, term, neonatal morbidities. Introduction: There are an increasing number of babies born at gestations of 34 to 36 weeks due to various obstetric and neonatal reasons. Due to better newborn and maternal care, obstetricians are delivering neonates at this gestation. Babies born at this gestation were considered as near term babies and equivalent to term babies. It was believed that these babies will have fewer problems postnatally and will do well with routine newborn care meant for a normal baby and therefore they never received the attention they deserved. It is now realized that babies born at 34 to 36 weeks should not be considered as term babies as the magnitude of morbidities in these subset of babies is much higher. These babies should therefore be considered as late preterms. Much has been spoken and written about problems of the preterm (less than 34 weeks) but little is available on babies above this gestation. The available literature is mainly from the western nations. The obstetric and newborn care in these countries is different from a developing country like India. There is very limited data available on the problems regarding late preterm babies in India. There is an immense need to conduct a study, which will deal with the problems of the late preterm. Keeping these areas of concern in mind this study has been planned, which aims to address the short-term morbidities in late preterm babies in our hospital. This hospital is a tertiary care hospital in south Kerala with large number of admissions of preterm babies. Aims and objectives of the study: To compare morbidities in late preterm babies versus term babies. Primary outcomes: Need for resuscitation at birth Respiratory distress requiring oxygen, CPAP, ventilation and surfactant therapy Jaundice requiring treatment Feeding difficulties encountered and type of feeds at discharge. Secondary outcomes: To evaluate late preterm babies at 3 months of age corrected for prematurity for following: - Exclusive breast feeding Physical growth Development assessment with DDST (Denver development screening test). Subjects and methods: All consecutively born babies delivered in the hospital in the study period were subjected to gestation assessment. Gold standard for gestation assessment was considered as early obstetric ultrasound (6-12 weeks). In the absence of early ultrasound, and if the maternal menstrual history is reliable, the gestation was calculated from the date of last menstrual period. In the absence of both, the gestation was calculated from the clinical assessment of gestation by new Ballard score. Babies born preterm (<34 weeks) were excluded. The enrolled babies are divided in two groups: - 1 Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 15, Issue 15

2 Case: Gestation 34 to 36 weeks. Control: All consecutive term (above 36 weeks 6 days gestation) newborn babies born at KIMS during the study period. Maternal data The relevant maternal data is collected from the maternal records as follows:- 1. Antenatal steroids 2. Presence of and duration of true labor pain 3. Trial of induction 4. Indication for late preterm delivery (in case of study group) 5. Mode of delivery (normal / LSCS/ assisted) Baby details The details were recorded from the birth Performa and inpatient medical records. The Doctors follow up notes and nursing monitoring charts were used to collect the data. The following parameters were noted:- 1. Gestation 2. Sex 3. Birth weight Need for resuscitation The pediatric residents or the neonatal fellows attend all deliveries in this hospital and are trained in neonatal resuscitation programme (NRP). The details of resuscitation were recorded. The extent of resuscitation was recorded as initial steps, need of oxygen, positive pressure ventilation (PPV), chest compressions and need of medication. Respiratory morbidities The need of respiratory support was recorded as: - 1. Need of oxygen 2. Need of surfactant and /or ventilation Hypoglycemia Blood sugars were monitored as per unit protocol by glucometer. Hypoglycemia (less than 40 mg/dl) is confirmed by laboratory blood sugar. Feeding The hospital promotes exclusive breast feeding. The mothers were counseled by lactation counselors from birth of the baby till discharge from NICU. An exclusive breastfeeding rate at discharge from NICU and at 3 months chronological age was recorded. Neonatal jaundice: As a hospital policy, the serum bilirubin is done for all babies at 48 hours of birth. Further bilirubin estimation was done as per clinical need. The decision of phototherapy was taken on the basis hour specific serum bilirubin values as per AAP guidelines for the babies more than and an equal to35 weeks and on the basis of Cockington s charts for babies less than or equal to 34 weeks. The mode of treatment (phototherapy and exchange) was recorded. Sepsis: Sepsis was suspected on the basis of standard signs and symptoms. Following data was recorded: 1. Suspect sepsis (where antibiotics were given for at least 2 days on the basis of clinical suspicion and signs and symptoms of the baby) 2. Probable sepsis on the basis of positive sepsis screen (positive CRP) 3. Culture positive sepsis At discharge following parameters were recorded 1. Weight of the baby 2. Length of baby 3. Occipitofrontal circumference 4. In the study group (late preterm group) the number of days in the ICU was recorded. Secondary outcomes The late preterm babies (study group) were followed at 3 months of age corrected for prematurity and were assessed for the following: - 1. Physical growth length, weight, and occipitofrontal circumference 2. Development: neurodevelopment was assessed by the DDST (Denver Development Screening Test). The abnormalities were noted in all 4 parametersgross motor, fine motor, language and psychosocial parameters. Amiel Tison angles were also recorded. Hypertonia was considered as abnormal finding. Observations and results: Total number of babies enrolled in the study: Number of late preterm babies (cases): -114(8.9%). Number of term babies (controls):- 1094(84.4%). Number of babies less than 34 weeks gestation (excluded) 87(6.7%). Late preterm babies (cases) (n = 114) Confirmation of gestation by early ultrasound (less than 20 weeks): 97(85.08%). Number of babies born at 34weeks gestation: 34(29.8%). Number of babies born at 35 weeks gestation: 27(23.6%). Number of babies born at 36 weeks gestation: 53(46.9%) Male: Female ratio in late preterm babies: In study group population there were 32 (28%) babies in weight category less than 2 kg, 48 (42.2%) babies in kg category, 23(20.2%) babies in kg category and 11 (9.6%) babies who were more than 3 kg. In late preterm babies, the incidence of AGA was 80.7%. The incidence of SGA babies in the late preterm group was 11.4% and there were 7.8 % LGA babies. Cause of prematurity and morbidities in late preterm babies Preterm labor and PROM accounted for 53 cases (46.9%) for Prematurity in the study group while maternal /fetal factors such as PIH, GDM, antepartum hemorrhage, multiple gestation, fetal distress, abnormal doppler and meconium stained amniotic fluid. accounted for 61(53.5%) cases. Labor pain was present in 49.1% mother s of late preterm babies. 2 Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 15, Issue 15

3 Table 1: Correlation of cause of prematurity and morbidities in late preterm babies Cause Preterm labor/prom Maternal or fetal cause Need for Resuscitation (n=16) 6 (37.5%) 10 (62.5%) Respiratory support (n= 34) 13 (38.2%) 21 (61.7%) Correlation of cause of prematurity and morbidities in late preterm babies Hypoglycemia (n= 34) 9 (26.4%) 25 (73.6%) Exclusive breast feeding at discharge (n=61) 38 (62.3%) 23 (37.7%) Treatment for jaundice (n=58) 20 (34.4%) 38 (65.5%) Sepsis (n=11) 2 (18.2%) 9 (82%) Fluid therapy (n=66) 24 (36.4%) 42 (63.6%) Antenatal steroids Out of 114 babies in the late preterm group, mothers of 66 babies (57.8%) had not received steroids antenatally while 16 (14.1%) mothers had received an incomplete course while 32 (28.1%) have received the full course. Table 2: Incidence of treatment with antenatal steroids Mode of delivery: Cesarean section accounted for 99 (86.8%) births while 12 (10.5%) babies were delivered by vaginal route and 3 (2.6%) required assisted delivery. Table 3: Distribution of mode of delivery Mode of delivery Number (%) Cesarean section 99 (86.8%) Normal delivery 12(10.5%) Vacuum extraction 3 (2.6 %) Table 4: Comparison of Short-term morbidities - late preterm babies vs. term babies Morbidity Late preterm (n=114) Term (n=1094) Need for resuscitation 16(14%) 18(1.7%) Respiratory support 34(29.8%) 38(3.4%) Hypoglycemia 34(30%) 25(2.2%) Exclusive breast feeding 61(53.5 %) 93.67% * Need for treatment for neonatal jaundice 58(50.8%) 114(10.4%) Sepsis (CRP >10 mg / L) 11(9.6%) 10(0.9%) Intravenous fluid therapy *Sample survey of 80 consecutive babies 66(57.8%) 24(2.1%) Table 5: Comparison of morbidities as per gestation in late preterm babies Morbidity 34 weeks (n=34) 35weeks (n=27) 36weeks (n=53) Need for 6(17.6%) 5(18.5%) 5(9.4%) resuscitation Respiratory support 12(35.2%) 10(37.03%) 12(22.6%) Hypoglycemia 8(23.5%) 11(40.7%) 15(28.3%) Exclusive breast 13(38.2%) 16(59.2%) 32(60.3%) feeding at discharge Treatment for 23(67.3%) 12(44.4%) 23(43.3%) neonatal jaundice Sepsis 2(5%) 3(11.1%) 6(11.3%) Intravenous fluid therapy Antenatal Steroids Number (%) No steroids 66 (57.8%) Incomplete course 16 (14.1%) Complete course 32 (28.1%) 28(82.3%) 16(59.2%) 22(41.5%) Need for resuscitation In our study, 14% late preterm babies (n=114) required some resuscitation as compared to only 1.7% term babies (n=1094). The need for resuscitation - Initial steps of resuscitation (4.3 % vs. 0.4 %), Positive pressure ventilation at birth (9.7 % vs. 1.3 %) and Intubation (0.8 % vs %) were higher in late preterm when compared to term born. None of the babies in the study period required chest compressions or medications for resuscitation. The need for resuscitation was higher at 34 and 35 weeks as against babies born at 36 weeks (18 % vs. 9 %). Feeding difficulties 53.5 % of late preterm babies were fed only breast milk at discharge from NICU. The others were receiving supplemental formula feeds. Only 50.6% babies of late preterm gestation were on exclusive breastfeeding at 3 months of age. Secondary outcomes Total number of babies in late preterm group (study group): Number of babies followed up at 3 months of corrected age: - 83 (72.8%). Number of babies lost to follow up: - 31 (27.2%). Table 6: Gestational age wise distribution of late preterm babies Gestational age (n) Number (%) 34 weeks (n=34) 8(23.5%) 35 weeks (n=27) 8(29.6%) 36 weeks (n=53) 15(28.3%) Table 7: Weight At 3 months of age corrected for prematurity Weight category Number (%) >50 th centile 11(13.2%) 5 50 centile 69 (83.1%) < 5 th centile 03 (3.6%) Table 8: Development assessment at 3 months of age corrected for Prematurity Developmental outcome at 3months Number (%) Normal 63 (73%) Abnormal 04 (4.8%) Questionable 17(20.4%) More than 1 abnormal 01(1.2%) More than 1 questionable 03 (3.6%) 3 Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 15, Issue 15

4 Discussion: Our study compared the short-term morbidities of babies born late preterm (n= 114) with babies born at term gestation (n = 1094) in Indian population. The strengths of our study in relation to previously published data are that we have enrolled all consecutive babies in the study period. Ours is a prospective case control study. Wang et al 1 studied 90 late preterm babies and compared with 95 full term babies. This study was a retrospective study obtained from medical records. Also, the babies in the two groups were selected randomly from a larger population. This could result in bias. In 85 % pregnancies confirmation of gestation was based on early ultrasound scans. This is comparable to other studies. In the study period (18 months) 8.9 % of the 1295 babies were born late preterm % babies were delivered at term gestation was the control group. 6.7 % babies were delivered before 34 weeks and excluded from analysis. In the United States the proportion of late preterm babies has increased from 7.3 % in 1990 to 9.1 % in [2] 56 % of all preterm babies in our hospital were late preterm and 44 % were less than 34 weeks. In USA in 2005 late preterm babies constituted 70 % of premature births and only 30 % were born before 34 weeks [3]. Our hospital serves as a referral center for neighboring districts and the high incidence of prematurity may reflect selective referral of high risk pregnancies. 29.8% babies were born at 34 weeks, 23.6% at 35 weeks and 46.9% at 36 weeks gestation. At all gestations 11 % babies were SGA. 81 % were AGA in birth weight and 8 % were LGA. There was nearly equal sex distribution (1.19, M: F). The late preterm babies were at increased risk of neonatal morbidities or need for NICU care (need for resuscitation, respiratory distress, hypoglycemia, hyperbilirubinemia, investigation for suspect sepsis, feeding problems and need for intravenous fluids) as compared to term born babies (85 % vs %). This finding is similar to a population study from United States which has found seven times increased morbidities (respiratory distress, hypoglycemia, hyperbilirubinemia, temperature instability and prolonged hospitalization) in early neonatal period (22 % vs. 3 %). The higher incidence of morbidities in term babies may be related to referral nature of our hospital. In our study, the late preterm 14% babies required some resuscitation as compared to only 1.7% term babies (n=1094). The need for resuscitation - Initial steps of resuscitation (4.3 % vs 0.4 %), Positive pressure ventilation at birth (9.7 % vs 1.3 %) and Intubation (0.8 % vs %) were higher in late preterm when compared to term born. None of the babies in the study period required chest compressions or medications for resuscitation. The need for resuscitation was higher at 34 and 35 weeks as against babies born at 36 weeks (18 % vs 9 %). Respiratory support in the form of oxygen by hood, ventilation, and surfactant administration was required in 29.8% late preterm babies as against 3.4% in term babies. 9.6 % late preterm babies were ventilated as against 0.2 % term babies. One baby in late preterm group received surfactant. Previous studies have shown respiratory distress to be commoner in late preterm as against term Wagh S Amargeet and Jain Naveen / JPBMS, 2012, 15 (9) babies. (10.7 vs. 2.7% Escobar et al 4, 9.6 vs. 0.6 % Rubaltelli et al., [5], 28.9 vs. 4.2 % Wang et al). Gilbert et al reported 3.4 % vs. 0.9 % need for ventilation in late preterm against term babies. In our study, 34 and 35 week babies required respiratory support in % whereas at 36 weeks lesser babies required respiratory support (22 %). Hypoglycemia (Symptomatic or Asymptomatic) defined as blood sugar below 40mg/dl was seen in 30% babies in the late preterm group as compared to 2.2% in term babies. The blood sugar estimation was mostly by Dextrostix and lab confirmation was not available in all cases. Only sick term babies had glucose estimation. Wang et al have reported 15.6 % vs. 5.3 % hypoglycemia in late preterm vs. term babies. Our hospital has two lactation consultants who promote exclusive breast feeding in non sick term and preterm neonates. Even among babies in NICU, mothers are encouraged to maximize breast milk feeding % of late preterm babies were fed only breast milk at discharge from NICU. The others were receiving supplemental formula feeds. A survey of 80 consecutive term babies showed 93.7 % babies to be exclusively breast fed at discharge. It was possible for 60 % at 35 and 36 weeks of gestation to be discharged on exclusive breast-feeding, but only 38.2% babies born at 34 weeks were exclusively on breast milk at discharge from NICU. At 3 month chronological age 50.6 % of late preterm babies were still exclusively breast fed. Wang et al have described feeding difficulties to be more in late preterm as compared to term (32.2 vs. 7.4 %). Neonatal hyperbilirubinemia requiring treatment in the form of Phototherapy was much higher in late preterm babies as compared to term babies (50.8 vs. 10.4%). Our study also revealed that more babies % at 34 weeks of gestation required treatment for jaundice as compared to 44 % at 35 and 36 weeks gestation. Wang et al found need for phototherapy to be similar in late preterm (54.4 %). Neonatal jaundice caused delay in discharge in 16.3 % late preterm babies vs % babies. More babies were evaluated for sepsis and received empirical antibiotics in late preterm babies as compared to term born (32 vs1.9%). There was a marked difference in the incidence of neonatal sepsis in the late preterm vs. term babies (9.6% vs. 0.9%). In Wang s study 36 % of late preterm babies were evaluated for sepsis as against 12.6 % of term babies. Late preterm had greater requirement of intravenous fluid and hence NICU care for the same compared to term controls (57.8% vs. 2.1%). If the baby was delivered late preterm for maternal or fetal illness, neonatal morbidities were more as against delivery because of preterm labor / premature ROM. Preterm labor and premature rupture of membranes accounted for 46.9% of late preterm, while maternal /fetal factors such as PIH, GDM, antepartum hemorrhage, multiple gestation, fetal distress, abnormal Doppler and meconium stained amniotic fluid accounted for 53.5% cases. Need for resuscitation, need for respiratory support, hypoglycemia, hyperbilirubinemia, sepsis and need for intravenous fluids were less in late preterm delivered for preterm labor 4 Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 15, Issue 15

5 compared to delivery for maternal or fetal risk (37 vs. 62, 38 vs. 62, 26 vs. 73, 34 vs. 65, 18 vs. 81, 36 vs. 64 % respectively). It was seen that 16 (14.1%) mothers received incomplete course of antenatal steroids and 32 (28.1%) received the full course. This number is surprisingly high considering the anticipated benefits and recommendation of use till 34 weeks pregnancy. The use of antenatal steroids did not decrease incidence of any neonatal morbidity. Of the 114 babies in the study 86.8% were delivered by cesarean section while only 10.5% were delivered by vaginal route and 2.6% by assisted vaginal deliveries. 49 % mothers experienced true labor pain before delivery of the late preterm babies. The cesarean rates at this hospital were higher because a sizeable proportion of mothers were referred for antenatal problems. The study population was followed up at 3 months of age corrected for prematurity. Out of 114 babies in the study group, 83 (72.8%) babies were available for follow up. 31 babies (27.2%) were lost to follow up. Babies who were lost to follow up were not disproportionately represented in any of the gestations. Of the 83 babies followed at 3 months corrected age, 3.6% had weight less than 5 th centile, 83 % babies had weight in between 5 th 50 th centile and 13% more than 50 th centile. The development outcomes of the babies in the study group were assessed by the DDST (Denver development assessment test) at 3 months of age corrected for prematurity. 20 babies (24%) were found to have abnormal or questionable DDST. Drawbacks of the study The study population is derived from tertiary care referral center where significant proportions of mothers are referred for antenatal problems. Therefore a higher incidence of morbidities may be observable in the late preterm population. Higher incidence of cesarean sections predisposes the late preterm group to respiratory morbidities like Transient tachypnoea of newborn (TTN). Wagh S Amargeet and Jain Naveen et. al. / JPBMS, 2012, 15 (09) Assessment of breast feeding in term babies at 3 months follow up has been done on a sample survey of 80 consecutive babies and not on the entire control group because of logistic issues. Assessment of jaundice at 34 weeks gestation has been done using the Cockington charts, which are less rigorously validated for assessing severity of jaundice in late preterms. However since the hour specific bilirubin nomogram is designed for use in babies above 34 weeks, it could not have been used in the 34 week gestation group. This study has looked at a short term neurodevelopmental follow up which may be inadequate in order to draw firm conclusions about the true incidence of neurodevelopmental disability in this high risk age group. Strengths of the study 1. This study is a prospective observational study over a period of 18 months conducted at a tertiary care center with wide variety of late preterm problems which were addressed in the study. 2. Enrollment of the late preterms has been done consecutively. 3. The need for resuscitation in late preterms has previously not been compared. 4. We have a structured follow up clinic for NICU graduates and 75 % babies were followed till 3 months age corrected for Prematurity. The babies who were lost to follow up were not disproportionately represented in any of the gestational categories. 5.The late preterm morbidities were sub grouped into prematurity due to Maternal /fetal risk factors and due to Idiopathic preterm labor / PROM which has not been addressed earlier. Acknowledgements: Dr. MI Sahadulla, CMD, KIMS for the assistance in organizing the Neurodevelopment Follow Up clinic at KIMS. Kavitha S, Developmental therapist, for the development tests and her assistance in data collection. Smitha K, Developmental therapist, for the development tests and her assistance in data collection. References: 1.Wang ML, Dorer DJ, Fleming MP, Catlin EA. Clinical outcomes of near-term infants. Pediatrics. 2004; 114: Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Munson ML. Births: final data for Natl Vital Stat Rep.2005; 54(2): Davidoff MJ, Dias T, Damus K, et al. Changes in the gestational age distribution among U.S. singleton births: impact on rates of late preterm birth, [published correction appears in Semin Perinatol. 2006; 30:313]. Semin Perinatol. 2006; 30: Escobar GJ, Clark RH, Greene JD. Short-term outcomes of infants born at 35 and 36 weeks gestation: we need to ask more questions. Semin Perinatol. 2006; 30: Rubaltelli FF, Bonafe L, Tangucci M, Spagnolo A, Dani C.Epidemiology of neonatal acute respiratory disorders. Biol Neonate.1998; 74:7 15. Conflict of Interest: - None Source of funding: - Not declared Corresponding Author:- Dr. Amarjeet Wagh, 138, Anjani Housing Society, Chandanshesh Nagar, Hudkeshwar Road, Nagpur , India. 5 Journal of Pharmaceutical and Biomedical Sciences (JPBMS), Vol. 15, Issue 15

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