Background
Oropharyngeal administration of colostrum (OAC) may provide immunoprotective and anti-inflammatory effects that potentially reduce the incidence of necrotizing enterocolitis (NEC) and late-onset sepsis (LOS) and improve short-term outcomes.
Objective
To evaluate the role of OAC in the early prevention of NEC and LOS in preterm infants with gestational age (GA) ≤ 32 weeks.
Methods
A randomized, placebo-controlled trial was conducted in a 40-bed tertiary neonatal intensive care unit (NICU) in China. Preterm infants with GA ≤ 32 weeks were divided randomly into an OAC group, which received 0.4 ml maternal colostrum smearing via the oropharyngeal route every 3 hours for 10 days beginning within the first 48 hours after birth, and a control group, which received normal saline instead. Data from the two groups were collected and compared.
Results
A total of 127 patients in the OAC group and 125 patients in the control group were finally enrolled. The incidence of NEC (Bell stage 2 or 3) and LOS was lower in the OAC group [2.4% vs. 10.4%, χ2 = 6.845, ༰=0.009; 4.7% vs. 13.6%, χ2 = 5.983, ༰=0.014]. In addition, the incidence of intraventricular hemorrhage (IVH) (stage 3 or 4) was lower [1.6% vs. 7.2%,χ2 = 4.775, ༰=0.029], and the time of achieving full enteral feeding was shorter [ 22.0 days vs. 25.0 days༌Z = 6༌424.500༌P = 0.009)] in the OAC group. No cases of adverse reactions were observed in either group.
Conclusions
OAC is a safe and simple NICU procedure that yields a potential advantage in decreasing the incidence of NEC, LOS, and severe IVH and shortening the time to achieve full enteral feeding in preterm infants with GA ≤ 32 weeks.
Trial registration
Chinese Clinical Trial Registry, ChiCTR1900023697, Registered 8 June 2019, Retrospectively registered, http://www.chictr.org.cn/edit.aspx? pid = 39398

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Posted 15 Jan, 2021
On 06 Mar, 2021
Received 04 Mar, 2021
Received 04 Mar, 2021
On 18 Feb, 2021
Received 19 Jan, 2021
On 18 Jan, 2021
Invitations sent on 18 Jan, 2021
On 18 Jan, 2021
On 09 Jan, 2021
On 09 Jan, 2021
On 09 Jan, 2021
On 08 Jan, 2021
Posted 15 Jan, 2021
On 06 Mar, 2021
Received 04 Mar, 2021
Received 04 Mar, 2021
On 18 Feb, 2021
Received 19 Jan, 2021
On 18 Jan, 2021
Invitations sent on 18 Jan, 2021
On 18 Jan, 2021
On 09 Jan, 2021
On 09 Jan, 2021
On 09 Jan, 2021
On 08 Jan, 2021
Background
Oropharyngeal administration of colostrum (OAC) may provide immunoprotective and anti-inflammatory effects that potentially reduce the incidence of necrotizing enterocolitis (NEC) and late-onset sepsis (LOS) and improve short-term outcomes.
Objective
To evaluate the role of OAC in the early prevention of NEC and LOS in preterm infants with gestational age (GA) ≤ 32 weeks.
Methods
A randomized, placebo-controlled trial was conducted in a 40-bed tertiary neonatal intensive care unit (NICU) in China. Preterm infants with GA ≤ 32 weeks were divided randomly into an OAC group, which received 0.4 ml maternal colostrum smearing via the oropharyngeal route every 3 hours for 10 days beginning within the first 48 hours after birth, and a control group, which received normal saline instead. Data from the two groups were collected and compared.
Results
A total of 127 patients in the OAC group and 125 patients in the control group were finally enrolled. The incidence of NEC (Bell stage 2 or 3) and LOS was lower in the OAC group [2.4% vs. 10.4%, χ2 = 6.845, ༰=0.009; 4.7% vs. 13.6%, χ2 = 5.983, ༰=0.014]. In addition, the incidence of intraventricular hemorrhage (IVH) (stage 3 or 4) was lower [1.6% vs. 7.2%,χ2 = 4.775, ༰=0.029], and the time of achieving full enteral feeding was shorter [ 22.0 days vs. 25.0 days༌Z = 6༌424.500༌P = 0.009)] in the OAC group. No cases of adverse reactions were observed in either group.
Conclusions
OAC is a safe and simple NICU procedure that yields a potential advantage in decreasing the incidence of NEC, LOS, and severe IVH and shortening the time to achieve full enteral feeding in preterm infants with GA ≤ 32 weeks.
Trial registration
Chinese Clinical Trial Registry, ChiCTR1900023697, Registered 8 June 2019, Retrospectively registered, http://www.chictr.org.cn/edit.aspx? pid = 39398

Figure 1

Figure 2

Figure 3
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