Neonatal and Newborn

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 http://evolve.elsevier.com/McCuistion/pharmacology

This chapter focuses on drugs commonly administered to the neonate, which includes late preterm newborns immediately after delivery.
As discussed in Chapter 49, A thorough medical history, such as acquired immunodeficiency syndrome (AIDS), Group B streptococcal infection, and viral hepatitis B or hepatitis C should be conducted. Labor is determined to be preterm if it commences before 37 weeks of pregnancy. If there are no contraindications to halting preterm labor, tocolytic therapy is administered to delay birth (see Chapter 49 for more information on pregnancy and preterm labor drugs). However, when preterm labor is not arrested, premature delivery of the neonate occurs, which puts the newborn at risk for health problems. Premature neonates are at risk for respiratory distress, hypothermia, hypoglycemia, and hyperbilirubinemia, and they may have feeding difficulties.

Drug Administered to Preterm Neonates

Synthetic Surfactant

Respiratory distress syndrome (RDS) can occur because of immature lung development and breathing control and decreased airway muscle tone and surfactant level. Surfactant, a lipoprotein, is necessary to decrease the surface tension of the alveoli (air sacs) to allow the lungs to fill with air and prevent the alveoli from deflating. Immature lungs have lower than normal levels of surfactant; the more premature the neonate is, the higher the chance of RDS. One approach used to minimize respiratory difficulties in the preterm neonate is surfactant replacement. Supplementing the amount of endogenous surfactant available to maintain distension of the alveolar sacs is the focus of this therapy.
The U.S. Food and Drug Administration (FDA) has approved the use of beractant, calfactant, and poractant alfa. Beractant intratracheal suspension, a natural bovine lung extract, contains phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins to which colfosceril palmitate (dipalmitoylphosphatidylcholine, or DPPC), palmitic acid, and tripalmitin are added. Beractant does not require reconstitution. Calfactant also does not require reconstitution, nor does it need to be warmed at room temperature prior to use, unlike beractant and poractant. Poractant alfa is porcine lung surfactant and is indicated for rescue treatment, whereas beractant and calfactant are approved for prophylaxis and rescue treatment. Poractant should be slowly warmed to room temperature and also does not need reconstitution. Each of these products defines prophylactic and rescue use differently and has different dosing and administration requirements. Table 51.1 lists the surfactant drugs used for prevention and treatment of RDS along with their dosages, uses, and considerations.

TABLE 51.1

Exogenous Surfactant Therapy for Prevention and Treatment of Respiratory Distress Syndrome

Generic Route and Dosage Uses and Considerations
Beractant PN: IT: 4 mL/kg per dose divided into four equal amounts; administer each quarter amount followed by repositioning and extra ventilation; repeat q6h.
Bovine-derived surfactant to be administered IT for prophylaxis and treatment of RDS in premature infants <1250 g birthweight or with evidence of surfactant deficiency within 15 min of birth or neonate with confirmed RDS requiring ET intubation by 8 h.
Drug must be given by health care personnel experienced with using ventilators for prevention or rescue in treatment of RDS.
Administer through a 5-French end-hole catheter as a dosing catheter inserted into an ET tube; do not shake; warm 20 min at room temperature or in the hand for at least 8 min.
Reposition infant to distribute drug followed by ventilation for 20 s after each quarter dose.
Does not affect the CYP450 isoenzymes.
Calfactant PN: IT: 3 mL/kg per dose divided in two equal amounts; administer each half amount over a total of 20-30 breaths during the inspiratory phase followed by repositioning and monitoring respiratory status; repeat q12h.
Calf-derived surfactant to be administered IT for prophylaxis and treatment of RDS in premature infants <29 wk of gestational age at risk for RDS or ≤72 h of age with RDS requiring ET intubation.
Drug must be given by health care personnel experienced with ventilators and RDS.
Gently swirl the vial to ensure a uniform suspension; avoid foaming.
Draw dose with a 20-gauge needle; do not filter or dilute; administer via a 5-French end-hole catheter inserted into the proximal end of the ET tube.
Poractant alfa PN: IT: 2.5 mL/kg per dose divided in two equal amounts; administer each half amount to each main bronchus followed by repositioning and monitoring respiratory status; repeat q12h.
Porcine-derived surfactant to be administered IT for the treatment of RDS in premature infants within 15 h of birth.
Drug must be given by health care personnel experienced with ventilators and RDS.
Warm to room temperature; gently invert to obtain uniform suspension.
Draw dose with a 20-gauge or larger needle; do not filter or dilute; administer via a 5-French end-hole catheter inserted into the proximal end of the ET tube.

CYP450, Cytochrome P450; ET, endotracheal; h, hour; IT, intratracheally; min, minute; PN, premature neonate; q, every; RDS, respiratory distress syndrome; s, second; wk, weeks; <, less than; ≤, less than or equal to.

All exogenous surfactants require a patent endotracheal (ET) tube for administration and specified alterations in positioning the infant throughout the procedure to ensure even drug dispersion. These precise position changes allow gravity to assist in the distribution of the product in the lungs, particularly at the alveolar surface.
Crackles and moist breath sounds may be a transient finding after administration of these products, particularly with beractant. Exogenous surfactant can cause postadministration complications such as hyperoxia (excessive oxygenation) and hypocarbia (decreased carbon dioxide [CO2]). Additionally, transient endotracheal reflux can obstruct the ET tube and lead to oxygen desaturation, cyanosis, bradycardia, and apnea. These issues do not usually lead to serious long-term complications when properly managed. Unless obvious signs of airway obstruction are noted, suctioning should not be performed immediately after administration of supplemental surfactant. Dosing is slowed or halted if the infant (1) becomes dusky colored, (2) becomes agitated, (3) experiences transient bradycardia, (4) has oxygen saturation increases of more than 95%, (5) experiences improved chest expansion, or (6) has arterial or transcutaneous CO2 levels below 30 mm Hg. Suctioning before dosing decreases the chance for ET tube blockage during dosing. No long-term complications or sequelae of synthetic surfactant therapy have been reported. Surfactant replacement therapy has been found effective in reducing the severity of RDS; rapid improvements in lung compliance and oxygenation may require immediate decreases in ventilator settings to prevent lung overdistension and pulmonary air leak.
 
icon Nursing Process: Patient-Centered Collaborative Care
Drug Administered to Preterm Neonate: Synthetic Surfactant

Assessment

• Obtain informed consent. Separate consents are needed for multifetal births.
• Assess the infant’s vital signs, perform a physical examination, and monitor arterial blood gases (ABGs).

Nursing Diagnoses

• Gas Exchange, Impaired related to inadequate lung surfactant secondary to fetal immaturity
• Knowledge, Deficient (parents) related to treatment needs of the infant

Planning

• The infant’s oxygen requirement and respiratory effort will decrease.
• The infant’s need for mechanical ventilation will be quickly reduced.
• The infant will experience no respiratory distress after surfactant administration.

Nursing Interventions

• Maintain a patent airway.
• Continuously monitor the infant’s vital signs before, during, and after surfactant therapy. Ventilation-perfusion matching can occur rapidly after administering surfactant. Anticipate the need to alter ventilator settings.

TABLE 51.2

Drugs Administered to Newborns

Generic Route and Dosage Uses and Considerations
Erythromycin ophthalmic ointment Within 1 h of delivery and without touching the tip of the tube to the eye, fingertips, or any other surface, place a 1-cm ribbon of ointment in the lower conjunctival sac of each eye, beginning at the inner canthus.
Prevention of ophthalmia neonatorum, an eye infection among newborns, and protection against gonococcal and chlamydial conjunctivitis.
Most states mandate erythromycin ophthalmic ointment, but consult your facility’s policy.
Hepatitis B immune globulin (HBIG) IM: 0.5 mL within 12 h after birth into the anterolateral thigh (vastus lateralis) For newborns of mothers positive for HBsAg for passive immunity; obtain consents from parents. Initiate recombinant HB as a separate injection at different sites; aspiration is not required.
Phytonadione 0.51 mg into the anterolateral thigh (vastus lateralis) within 1 h after birth; check health care provider or agency standing orders for dosage.
An anticoagulant antagonist for prevention of hemorrhagic disease of the newborn.
Drug is readily absorbed after IM administration.
Recombinant hepatitis B IM/Subcut: 0.5 mL (5 mcg) within 12 h after birth (first dose); subsequent doses at 1 and 6 mo of age into anterolateral thigh (vastus lateralis) Stimulates the immune system to produce anti–HBsAg antibodies without the risk of developing active infection. Because hepatitis D occurs only in persons infected with hepatitis B, recombinant HB protects against hepatitis D. Protection usually occurs 1 mo after the third dose.

h, Hour; HB, hepatitis B; HBsAg, hepatitis B surface antigen; IM, intramuscularly; mo, month; Subcut, subcutaneous.

• Maintain adequate respiratory status.
• Have a multidisciplinary team at the bedside.
• Monitor ABGs and obtain a chest radiography study.
• Prepare and administer drug according to the manufacturer’s drug insert.
• Do not perform ET suction immediately after administration of surfactant unless signs of airway obstruction are present.
• Position and reposition the infant as needed for equal distribution of surfactant throughout the lungs.
• Support and educate parents.
• Acknowledge the parents’ concerns regarding the well-being of the newborn.

Patient Teaching

• Explain to parents what RDS is and how surfactant helps the neonate.
• Explain to parents the purpose of multiple monitoring devices to reduce unrealistic fears about the neonate’s condition.
• Ensure informed consent for drug usage.
• Encourage parents to verbalize their understanding about risks associated with use of the drug.

icon Cultural Considerations

• Provide an interpreter with same ethnic background and gender if possible, especially with sensitive topics.
• Provide health information written in the patient’s primary language.

Evaluation

• Evaluate preadministration breath sounds, ABGs, respiratory status, and ventilator pressure readings to compare with postadministration findings.
• Evaluate the effectiveness of teaching to parents.

Drugs Administered to Full-Term, Healthy Neonates

According to the World Health Organization (WHO, 2016), newborns should receive eye care (e.g., erythromycin ophthalmic ointment), phytonadione, and immunizations for hepatitis B. Additionally, an antiinfective agent (e.g., chlorhexidine) may be applied to the cord stump during the first few hours after birth and for up to 1 week for at-risk newborns and newborns born in homes.

Erythromycin Ophthalmic Ointment

A common antiinfective administered to a newborn’s eyes within the first hour of birth is erythromycin ophthalmic ointment. It is given as a prophylaxis against eye infections; side effects include chemical conjunctivitis in about 20% of neonates, manifesting as edema and inflammation that lasts about 24 to 48 hours. It may interfere slightly with eye-to-eye contact between parents and the neonate.

Phytonadione

Phytonadione, a synthetic vitamin K, is a fat-soluble vitamin given to newborns to prevent vitamin K–deficiency bleeding (VKDB). It is administered as a single-dose injection. Side effects include pain and edema at the injection site. Some allergic reactions, manifested by urticaria and rash, have been reported. Neonates who receive larger doses may exhibit hyperbilirubinemia and jaundice resulting from competition for binding sites.
Table 51.2 covers erythromycin and phytonadione and their dosages, uses, and considerations.

Immunizations

The American Academy of Pediatrics and the Centers for Disease Control and Prevention (CDC) have recommended that immunization against hepatitis B virus (HBV) begin in the newborn period. HBV infection may result in serious long-term liver disease, cancer, and death in adulthood. The goal of immunization is to reduce the number of chronic carriers of the virus in the population, thus decreasing the prevalence of HBV infection.
In pregnancy, HBV transmission occurs vertically—that is, by perinatal transmission—primarily at the time of delivery. Hepatitis B immune globulin (HBIG) is given to infants born to mothers who are positive for hepatitis B surface antigen (HBsAg). HBIG provides the newborn passive protection against HBV. Adverse effects of the injection include pain, tenderness, and erythema at the injection site. Hypotension, erythematous rash, and anaphylaxis after receiving HBIG can also occur.
A three-dose series vaccine for hepatitis B, recombinant hepatitis B, is indicated for HBV prophylaxis in infants; the first injection is given at birth. Recombinant hepatitis B (HB) can provide active immunity against HBV by stimulating the immune system to produce antibodies against hepatitis B (anti–hepatitis B antigen), and it can be given concurrently with HBIG if the infant is born to an HBsAg-positive mother. Recombinant HB is given as separate injection administered to separate sites. Adverse effects from recombinant HB are generally mild and include pain, tenderness, pruritus, erythema, swelling, and induration at the injection site.
Table 51.2 lists HBIG and recombinant HB and their dosages, uses, and considerations.
 
icon Nursing Process: Patient-Centered Collaborative Care
Drugs Administered to Full-Term, Healthy Neonates

Assessment

• Assess the newborn for signs of distress such as cyanosis, bleeding, ecchymosis, apnea, fever, and hypotension.
• Assess the mother’s HB status.
• Assess the parents’ knowledge of treatments (e.g., medications and immunizations) given to their newborn.

Nursing Diagnoses

• Injury, Risk for neonatal
• Knowledge, Deficient parental related to immunization misinformation

Planning

• The neonate will experience minimal or no side effects from drugs routinely administered after delivery.
• Parents will express understanding of medications and immunizations given to their newborn.

Nursing Interventions

• Obtain parental consents for immunizations.
• Do not delay skin-to-skin contact between mother and infant while preparing medications and immunizations. Skin-to-skin contact in the first hour of birth prevents hypothermia and promotes breastfeeding.
• Wear gloves for administration of medications and immunizations.
• If the mother is HBsAg positive, prepare to administer HBIG to the infant.
• Prepare and administer drugs and immunizations according to the manufacturer’s instructions while the infant maintains contact with the mother’s skin.
• Administer erythromycin ophthalmic ointment before administration of phytonadione and hepatitis B injections. The infant may cry after injections, making administration of ophthalmic ointment more difficult.
• Monitor for any reactions, such as redness and swelling in and around the eye from the eye ointment or redness, swelling, or ecchymosis at injection sites. Monitor for any respiratory distress (e.g., grunting, apnea, nasal flaring).
• Acknowledge parent concerns about immunizations.
• Provide printed literature on hepatitis B and other immunizations.

Patient Teaching

• Instruct parents regarding the action, purpose, and side effects of medications and immunizations.
• Inform parents that any edema around the eyes usually disappears within 24 to 48 hours.
• Explain to parents the difference between HBIG and recombinant HB injections.
• Instruct parents regarding childhood immunizations as recommended by current immunization schedules, and inform them when repeat doses should be given. Give parents written information regarding the infant’s immunization record and vaccination schedule. Document administration of hepatitis B vaccine on the infant’s immunization record.
• Instruct parents on the signs and symptoms of adverse effects and when to notify the nurse.

icon Cultural Considerations

• Cultural values influence infant care. It is important for nurses to be culturally sensitive to the family’s cultural belief framework and to try to include this framework, as appropriate, in provision of care and establishing rapport with the patient and family members.

Evaluation

• Evaluate for newborn bleeding, particularly on days 2 and 3 after administration of phytonadione.
• Evaluate for drug hypersensitivity or side effects.
• Evaluate parents’ understanding about medications administered to their newborn.

Critical Thinking Case Study

TA, an older adolescent, was admitted to the hospital for labor induction/augmentation with signs and symptoms of gestational hypertension at 42 weeks’ gestation (gravida 4, para 1). TA’s mother arrived at the hospital when TA was dilated 8 cm and in time for the late stages of TA’s labor. Her mother remained as TA’s support person throughout the delivery, which occurred at 6:00 AM by vacuum extraction. TA had a continuous epidural for her labor and delivery. An episiotomy was performed at the time of delivery, and a fourth-degree laceration occurred. A cluster of hemorrhoids was evident. Baby JA, weighing 8 lb 7 oz, had Apgar scores of 7 and 9. The infant is alert and active.
TA lives with her parents and has been going to high school while working part time in an automotive parts store. She wants to keep her infant and to breastfeed “for at least 3 months.” She plans to finish school and return to work in 6 weeks.
Immediately after the delivery, the nurse conducts an assessment of TA, analyzes the data, and determines and prioritizes TA’s nursing care needs. The same is done for the newborn.
1. Within the standard, how should bonding be promoted—including eye contact between mother and infant—while eye prophylaxis is being administered?
2. Including safety for the nurse administering the ointment, what steps should the nurse follow to instill ointment into the infant’s eyes?
3. What should TA be taught about the side effects of eye prophylaxis?
4. How should the nurse explain the reason for the vitamin K injection for the infant in terms TA can understand?
5. Which newborns are eligible to receive the hepatitis B vaccine?
6. How many doses constitute the total series, and what is the duration for these?
7. Why is this vaccine given to newborns? Why is it important?

NCLEX Study Questions

1. A patient asks the nurse why her baby is receiving a vitamin K injection. The nurse’s best response is based on what knowledge?

a. Vitamin K causes an increase in newborn platelets.

b. A newborn’s liver is too immature to produce vitamin K.

c. A newborn lacks appropriate intestinal flora to synthesize vitamin K.

d. Vitamin K is not produced in bone marrow until an infant is 8 days old.

2. It is mandatory to have maternal signed consent before administering which newborn drug?

a. Erythromycin ophthalmic ointment

b. Phytonadione

c. Hepatitis B vaccine

d. Betamethasone

3. The nurse is mentoring a new graduate who is preparing to administer the phytonadione injection to a newborn. Which muscle sites selected by the new graduate would indicate the need for further teaching? (Select all that apply.)

a. Anterolateral thigh

b. Gluteus maximus

c. Rectus femoris

d. Vastus lateralis

e. Vastus medialis

4. The nurse is preparing to administer an ophthalmic drug to a newborn. Education for the parents includes which fact about the drug?

a. Infants of mothers who test positive for syphilis receive this medication.

b. Eye ointments are administered in the bottom of the eye from the inner to the outer eye.

c. This drug will prevent congenital cataracts.

d. Infants with a negative direct Coombs test receive this drug.

5. A newborn is admitted to the nursery, and the nurse reviews the maternal history. It is important that the nurse assess the mother’s status specific to which infectious process(es)? (Select all that apply.)

a. Rubeola

b. Hepatitis A

c. Hepatitis B

d. HIV/AIDS

e. Group B Streptococcus

6. A neonate whose mother is positive for the hepatitis B surface antigen (HBsAg) is admitted to the nursery. Which immunizations are appropriate for this neonate? (Select all that apply.)

a. Hepatitis B immune globulin (HBIG)

b. Recombinant hepatitis B (HB)

c. Haemophilus influenzae type B

d. Hepatitis A

e. Phytonadione

Answers: 1, c; 2, c; 3, a, d; 4, b; 5, c, d, e; 6, a, b, e.