Study design
We performed a cross-sectional study in the postnatal Unit of our Center between April and May 2020, during Italy’s lockdown [6]. Our hospital is a neonatal tertiary referral center, covering around 6000 pregnancies per year. It is located in Lombardy, Northern Italy, one of the Italian regions most early and severely affected by the current pandemic [7].
The Institutional Ethics Committee approved the present study, and written informed consent was obtained from all participants.
Study population
Enrollment began on April 7th, 2020, and was completed on May 10th, 2020. All consecutive mothers admitted to the postnatal Unit during the study period were assessed for eligibility within 48 hours of admission by a registered nurse or a neonatologist not directly involved in the care of the dyad. Inclusion criteria were: adequate oral and written comprehension of the Italian language, absence of underlying maternal or neonatal clinical conditions potentially impeding breastfeeding, a negative nasopharyngeal swab for Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), and signed written informed consent. Exclusion criteria were: inadequate oral and written comprehension of the Italian language, underlying maternal or neonatal clinical conditions potentially impeding breastfeeding, contraindications to breastfeeding (e.g., previous mastectomy, drugs incompatible with breastfeeding, chemotherapy), declared intention not to breastfeed, a positive nasopharyngeal swab for SARS-CoV-2, refusal to participate in the study.
Mothers were enrolled within 48 hours of admission and were requested to fill out the questionnaire created for the purposes of the present study during hospital stay, before discharge. Paper-based questionnaires were collected at discharge by a registered nurse or a neonatologist.
Newly implemented hospital policies:
Nasopharyngeal swabs
Consistently with our Center’s written protocol, every mother underwent a nasopharyngeal swab upon admission. Samples obtained before 4 pm were processed immediately and results took 6-8 hours to arrive; samples obtained after 4 pm were processed the next day.
Fathers and visits
Our postnatal Unit includes two types of rooms: Italian Public Healthcare System rooms (i.e., rooms paid for by the Italian Public Healthcare System-Servizio Sanitario Nazionale (SSN) –) and private rooms (i.e., paid for by the patients, either directly or through insurance). SSN rooms are double or triple rooms, whereas private rooms are single rooms. Health workers (gynecologists, obstetricians, neonatologists and nurses) who look after mothers and their newborns are the same, regardless of the type of room occupied. Likewise, breastfeeding promotion is offered to all dyads, following the Baby-Friendly Hospital Initiative [8] principles and the World Health Organization/United Nations Children's Fund Ten Steps to Successful Breastfeeding [9].
Since the beginning of the pandemic, visits in the postnatal Unit of our Center have been suspended, both for SSN and private rooms’ patients. Fathers’ daily and overnight presence has been allowed only in private rooms, in order to guarantee social distancing and avoid gatherings in SSN rooms.
Rooming-in and Breastfeeding
Rooming-in was allowed for mothers who tested negative for SARS-CoV-2. Following the recommendations of the Italian Society of Neonatology [10], asymptomatic or paucisymptomatic mothers who tested positive for SARS-CoV-2 or were still awaiting nasopharyngeal swab results stayed in a dedicated area of the postnatal Unit with their newborns. Conversely, rooming-in was not allowed for mothers with respiratory infection symptoms or impaired health status who tested positive for SARS-CoV-2 or were still awaiting results. Breastfeeding was recommended to every dyad, regardless of maternal SARS-CoV-2 status, provided that the appropriate mother-newborn infection control measures were implemented.
Instrument
The questionnaire used for the present study consisted of 4 subsections: 1. Sociodemographic information; 2. Breastfeeding; 3. Nurse Parent Support Tool (NPST); 4. State-Trait Anxiety Inventory-Form Y (STAI-Y). Subsections 1-2 were created by a neonatologist, an International Board Certified Lactation Consultant, a registered nurse and a neonatology resident. The first subsection included multiple-choice questions on maternal age, marital status, level of education, antenatal class attendance, breastfeeding as a topic addressed during antenatal class, mode of delivery, parity, current neonatal mode of feeding. Subsection 2 consisted of 4 questions: 2 multiple-choice and 2 open-ended questions. The first two questions addressed mothers’ pre-pandemic (a priori) and current intentions regarding breastfeeding. The 2 open-ended questions asked to specify how many months the mother intended to breastfeed or why she had decided not to breastfeed, depending on the answers given to the previous two multiple-choice questions. The NPST [11] is a 5-point Likert scale questionnaire used to assess parents' perception of nursing support received during hospitalization of their infant. The 21 items included in the questionnaire can be divided into 4 categories: Informational Support (9 items), Emotional Support (3 items), Appraisal/Parental Esteem Support (4 items), and Caregiving Support (5 items). Scores for each item range from 1 ("Almost never") to 5 ("Almost always"); higher scores show greater perceived support provided by the nursing staff. For each NPST, a total mean score and a subtotal mean score for each category were calculated.
The STAI-Y[12] is a self-assessment questionnaire commonly used to detect and evaluate anxiety both as a personality trait (TRAIT-A) and as a concurrent emotional state, subsequent to a specific situation (STATE-A). The STAI-Y comprises 40 questions (20/20); all items are rated on a 4-point Likert scale (from "Almost Never" to "Almost Always," or from "Not at all" to "Very much so"). Total scores for each part range from 20 to 80. Higher scores indicate greater anxiety. A score >=40 is considered indicative of clinically significant anxiety symptoms [13].
Mothers enrolled were offered the possibility to choose between a paper-based or online questionnaire. The online questionnaire was created using Google Forms (Google LLC, Mountain View, CA, USA) by a neonatology resident, and a link to the online form was sent to mothers via email from a Google account especially created for the present study. The paper-based and the online questionnaire were otherwise identical. Anonymity was guaranteed through the use of an alphanumeric code each mother was given at enrollment. The questionnaire took approximately 30 minutes to be filled out. Answers to online questionnaires were automatically inserted in an Excel spreadsheet, whereas answers from paper-based questionnaires were manually inserted in the same Excel spreadsheet by a neonatology resident. All data analyzed for the present study were obtained from the questionnaire, except neonatal data, which were retrieved from neonatal computerized medical charts (Neocare, i & t Informatica e Tecnologia Srl, Italy).
Statistical analysis
Data were analyzed from May 11th through May 20th, 2020. All participants who completed the questionnaire were included in the analysis. Categorical variables were expressed as numbers (frequencies) and compared between groups using the χ2 test. Continuous variables were tested for normality using the Kolmogorov-Smirnov test and expressed as mean (standard deviation) (SD) or median and Interquartile Range (IQR), depending on the normal or non-normal distribution of the variable, respectively. Continuous variables were subsequently compared between groups with the independent samples t-test or non-parametric tests, as appropriate.
Internal consistency of Nurse Parent Support Tool (NPST) and State-Trait Anxiety Inventory–Form Y (STAI-Y) was assessed employing Cronbach's α.
Univariate binary logistic regression models were used to examine correlations between STATE-A score (>=40 vs <40) and variables of interest: TRAIT-A score (>=40 vs <40), NPST score (<=4.23 vs >4.23), maternal age (<=35 years vs >35 years), parity (primiparous vs multiparous), mode of delivery (caesarean section vs vaginal delivery), marital status (single vs in a stable relationship), maternal education (>13 vs <=13 years), “SSN room” vs “private room”. Univariate binary logistic regression models were further used to examine correlations between exclusive breastfeeding at discharge (yes vs no) and variables of interest: maternal age (<=35 vs >35 years), parity (primiparous vs multiparous), mode of delivery (caesarean section vs vaginal delivery), STATE-A score, (>=40 vs <40), TRAIT-A score (>=40 vs <40), NPST score (<=4.23 vs >4.23), ante-natal class attendance (yes vs no), a priori choice to exclusively breastfeed (yes vs no). Variables significantly associated with the outcome were then fit in multivariable logistic regression models. For analysis purposes, NPST scores and maternal age were divided into two groups according to their median values.
Statistical significance was set at 2-sided P<.05. Statistical analysis was performed with SPSS version 21 statistic software package (SPSS Inc., Chicago, IL, USA).