This study received approval by the Institutional Review Board of Christiana Care Health System. All data were collected in a de-identified manner. This study in no way affected the routine medical care provided to infants at our Neonatal Intensive Care Unit (NICU).
Christiana Care Health System is a regional tertiary care teaching hospital located in Newark, Delaware with a 52 bed level 3 NICU. There are approximately 6500 deliveries and 1100 NICU admissions annually. At the time of this study there were 12 neonatologists and 55 obstetricians on staff in our institution.
After the release of the ACOG/AAP Committee Opinion in December 2012, a multi-disciplinary team was formed to review the recommendations and initiate a DCC program using quality improvement science. The team was comprised of NICU, Labor and Delivery and Perinatal nursing specialists, a NICU staff nurse, a neonatal research coordinator, a quality and safety data coordinator, a neonatologist, an obstetrician, a neonatal fellow, and a medical student. Working together with the leadership of the Obstetrics Department, the team developed a departmental policy on DCC. Furthermore, the team created individualized power point presentations for physicians and nursing staff to provide in-service education for nurses and grand rounds lectures for pediatric and obstetric providers. Committee members served as champions who addressed concerns of their own constituents. In addition, a detailed protocol for performing DCC was developed. Signage was displayed in each delivery room to ensure understanding of the proper technique.
We developed exclusion criteria for DCC based on local and national expertise. The exclusion criteria were: monochorionic-monoamniotic twins, any twin gestation with the second twin showing signs of distress, fetal asystole, complete abruptio placenta, anterior placenta, and any maternal condition requiring immediate attention, including maternal hypotension or cardiac arrest. Ultimately, it was the obstetrician’s decision to provide DCC in each delivery.
The multi-disciplinary committee developed a standardized DCC protocol, which was the same regardless of the mode of delivery. After the complete vaginal expulsion of the neonate or the extraction of the neonate from the uterus, our protocol called for delayed clamping of the umbilical cord for 60 s, which concurs with the 2012 ACOG/AAP recommendations of DCC for 30–60 s. During those 60 s, the neonate is wrapped in a warm, dry, sterile towel and for vaginal birth held 10 cm below the level of the introitus or, in the case of cesarean delivery, placed on the operating room table beside the mother. At any time, DCC could be stopped during a delivery at the discretion of the team managing the mother or baby. Apgar scores are reported from the time of delivery, not from the timing of cord clamping. A neonatal provider at the delivery verbally announced 15 s intervals and at 60 s the cord was clamped and cut and the infant was placed under the radiant warmer. In the early stages of the study there was a slight increase in the number of hypothermic patients. In response, the protocol was modified to sandwich the babies between 2 pre-warmed blankets during the 60 s of DCC in addition to the polyethylene wrap was used to improve thermoregulation once the baby was placed under the radiant warmer. Delivery rooms are maintained at 68 to 70° Fahrenheit. Following delivery and DCC, the NICU team provided care as needed. The routine care of the infant was in no way affected by our study and was in accordance with protocols already in existence at our facility. Resuscitation was performed utilizing the Neonatal Resuscitation Program guidelines published by the AAP .
Our initiative to provide delayed umbilical cord clamping began on July 1, 2013. Patients who qualified for DCC were all preterm (<37 weeks gestation) infants. However, for the ease of data collection and in order to focus on the highest risk population we only included inborn VLBW infants from July 1, 2012 to June 30, 2014 in our data analysis. This decision was predicated on the assumption that the population of VLBW infants is the one most likely to benefit from this intervention. We analyzed two cohorts; infants born before the DCC initiative from July 1, 2012 to June 30, 2013 (Cohort 1 – Pre-DCC) and infants born after the DCC initiative from July 1, 2013 to June 30, 2014 (Cohort 2 – Post-DCC). Our primary outcome measure was the effectiveness of our QI approach on the implementation of delayed cord clamping. With regards to the other clinical outcomes measured, we made an a priori decision to include all patients from Cohort 2 in the analysis, regardless if they received delayed cord clamping or not. In QI initiatives rarely is the entire population exposed to the intervention and by including all patients our data would be generalizable. Demographic information and clinical outcomes were obtained by thorough chart review. The data were recorded and saved on protected computers only available to the researchers. The demographic data included birthweight, gestational age, 1 and 5 min Apgar scores, and in-hospital mortality rates. Clinical outcomes collected included hypothermia upon NICU admission defined as less than 36 °C. Also packed red blood cell (pRBC) transfusion, respiratory support, phototherapy, early and late onset sepsis, IVH, periventricular leukomalacia, and necrotizing enterocolitis were tracked throughout the hospital stay. Sepsis was defined as a positive blood culture of a pathogenic organism. IVH is a known complication of preterm delivery  and was graded according to the system of Papile et al. . Severe IVH was defined as Grades 3 and 4. Periventricular leukomalacia was defined as necrosis of the periventricular white matter as noted on ultrasound . Necrotizing enterocolitis was defined as radiographic findings of gaseous distension of the bowel with pneumatosis or pneumoperitoneum along with associated clinical findings of abdominal distension and feeding intolerance . Balancing measures included use of phototherapy, as a marker for hyperbilirubinemia, and the incidence of hypothermia. The decision to transfuse was made clinically at the discretion of the attending neonatologist, in accordance with our unit’s recommendations based on the Premature Infants in Need of Transfusion (PINT) study . This transfusion policy did not change during the study period.
During the control phase of this initiative, we continue to monitor DCC compliance with monthly reports.
Continuous variables were analyzed by Student’s t-test and categorical data were compared using Chi square analysis. STATISTICA was used in data analysis. The manuscript was prepared using the Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0) Guidelines .